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21 Jobs Found 

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Clinical Research Associate (Freelance) - Ireland

Translational Research in Oncology

Dublin
30+ days ago
Dublin
30+ days ago

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

TRIO (Translational Research in Oncology) is a not-for-profit academic clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted therapeutic concepts in the clinical trial setting. We are committed to providing treatments of the future to the world of today.

We are looking for Clinical Research Associate Consultants (contract/freelance) to join our international team, home-based in Ireland. Our CRAs play a pivotal role in moving our important research forward and helping to save cancer patients’ lives all over the world.

TRIO’s head office is in Edmonton, Alberta with operations throughout Canada, the USA, France and Uruguay. The main objective of the Monitoring Resources team is to effectively monitor TRIO’s clinical trials according to contractual obligations and project deadlines according to the sponsor protocol and in compliance with the appropriate SOPs.

Reporting to a Monitoring Resources Coordinator, a CRA is responsible for the following:

  • Conducting site visits, including pre-study, initiation, monitoring and termination;
  • Confirming adherence to all FDA, ICH-GCP and local regulations;
  • Ensuring the completion and collection of regulatory documents;
  • Performing data verification of source documents;
  • Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
  • Participating in budget negotiation and follow-up where applicable;
  • Assisting with data validation and query resolution;
  • Mentoring junior team members as required.

Qualifications:

  • A minimum of 2 yearsof monitoringexperience in oncology trials
  • An advanced level of oncology knowledge
  • Completion of a science-related Bachelor’s degree
  • Excellentknowledgeofmedicalterminologyandclinicalmonitoringprocess
  • StrongICH-GCPsknowledge
  • Experiencewith clinical trial information systems
  • Ability to travel up to 60% on average

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QC Microbiology Analyst J04924

Independent Solutions

Limerick, Limerick
30+ days ago
Limerick, Limerick
30+ days ago
⦁ JobTitle:  
QC Microbiology Analyst J04924

⦁ About Company:
Our client based in Limerick is seeking a QC Microbiology Analyst to join its expanding team.

⦁ Duration of Job:
11 months. 25% shift allowance.

 ⦁ Summary Objective:
The QC Microbiology Analyst is responsible for assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures.


⦁ Job Duties:
• Perform routine environmental monitoring, product testing in line with company and regulatory specifications and trend associated data.
• Perform routine testing on water purification systems in line with company and regulatory specifications and trend associated data.
• Perform Quality Control on incoming media and test kits.
• Perform microbial identifications to ensure compliance with procedure and regulatory requirements.
• Perform validation and annual re-qualification of production Sterilisers and calibration of Validation equipment and document-associated data.
• Complete Annual re-qualification of laboratory Steriliser.
• Perform Process / Equipment / Facilities and Utilities Validation and document associated data.
• When required, Review and report Steriliser Non-conformances.
• Perform monthly run review of production sterilisers performance using statistical tools.
• Implement improved methodologies/processes for Lab processes.
• When required Perform microbiology assessment on engineering changes.
• Carry out safety inspections.
• Training of new microbiology laboratory technicians
• Providing Japan Distribution with Sterility Certificates for product
• Ensure Lab is supplied with consumables.
• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
• Creating, implementing and assessing change requests.
• Sterilizing and disposing of laboratory waste.



Requirements

⦁ Essential:

• Minimum of Certificate level qualification preferably in Microbiology or Biological Sciences.
• 2+ years industrial experience in the Pharmaceutical/Medical Devices Industry.

⦁ Desirable:

• Good knowledge of FDA and ISO requirements.
• Good organization skills and familiarity with computer packages.

Benefits

Benefits

Benefits of working with Independent Solutions

  • Benefit from Independent Solutions ethical principles!
  • We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency
  • While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team
  • We offer attractive rates - competitive margins compared to our competitors.
  • Payment on time and in full
  • We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
  • We work for you !


⦁ Essential: • Minimum of Certificate level qualification preferably in Microbiology or Biological Sciences. • 2+ years industrial experience in the Pharmaceutical/Medical Devices Industry. ⦁ Desirable: • Good knowledge of FDA and ISO requirements. • Good organization skills and familiarity with computer packages.
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Molecular Technologist

Charles River Laboratories

Dublin
12 days ago
Dublin
12 days ago
Molecular Technologist
Req ID: 94213
Location:
Dublin, IE, D09
For nearly 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Responsibilities
BASIC SUMMARY:
Process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping. Ensure adherence to regulatory requirements and GMP compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
+ Conduct accurate processing of customer samples in accordance with current SOPs.
+ Receive, unpack, log, and subculture customer samples according to current SOPs.
+ Aliquot and prepare reagents.
+ Perform test streaks for isolation, PCR, sequencing of customer samples and other laboratory processes including but not limited to mass spectrometry and ribotyping.
+ Perform continual maintenance, repair and cleaning of all laboratory equipment.
+ Perform pipette verification.
+ Operate and maintain laser cutter.
+ Provide backup for all laboratory functions when needed.
+ Dispose of microbe cultures, chemicals and glass in proper waste containers.
+ Collaborate with technical support to resolve discrepancies with customer samples.
+ Comply with all aspects of laboratory safety, safety stations, safety manuals, safety SOP, and MSDS sheets.
+ Suggest process improvements.
+ Perform or support special projects in the lab when needed.
+ Perform all other related duties as assigned.
Qualifications
+ Education:Bachelor’s Degree (B.A. /B.S.) in Microbiology or related discipline required.
+ Experience: 0-3 years related experience in a laboratory setting.
+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
+ Certification/Licensure:None.
+ Other:Must have working knowledge of the Quality System and Laboratory Information System. Must have ability to work in a fast paced and team oriented work environment. Strong attention to detail and accuracy required.
Who May Apply
The policy of Charles River Laboratories is to provide advancement opportunities to all qualified employees within the company through transfers or promotions.Regular Full and Part Time employees may apply for a Job Posting if they meet the eligibility requirements set forth in the Internal Job Posting policy.Regular Full and Part Time Employees must complete at least six months of continuous active service in their position prior to applying.Regular Full and Part Time Employees are eligible to participate in the Job Posting Process if their current overall performance appraisal rating is equivalent to "satisfactory" or better.Regular Full and Part Time Employees cannot be in any stage of a disciplinary action.Regular Full and Part Time Employees on leave of absence are not eligible to apply.
About Microbial SolutionsOur Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.
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QC Microbiology (Senior)

Adaptive HVM Ltd

Dun Laoghaire, Dublin
14 days ago
Dun Laoghaire, Dublin
14 days ago
This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Specific Job Duties:
• Environmental Monitoring of Grade 8/9 Cleanrooms
• Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports
• Water sampling
• Testing of In Process samples such as Protein Concentration, Density & pH


Requirements

Basic Qualifications
• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications
• Experience working in an aseptic cleanroom performing Environmental Monitoring
• Proficient in the use of LIMS & LMES

Competencies
• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
• Flexibility
• Problem solving skills
• Experience with Regulatory inspectors and interacting with inspectors desirable
• Demonstrated ability to work independently and deliver right first time results
• Works under minimal direction
• Work is guided by objectives of the department or assignment
• Follows procedures
• Refers to technical standards, principles, theories and precedents as needed
• May set project time-frames and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems
• Demonstrated leadership and communication skills
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies


Basic Qualifications • Bachelors degree in a science discipline • Biopharmaceutical QC experience in a microbiology lab • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Preferred Qualifications • Experience working in an aseptic cleanroom performing Environmental Monitoring • Proficient in the use of LIMS & LMES Competencies • Technically strong background in microbiology and aseptic manufacturing • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage • Flexibility • Problem solving skills • Experience with Regulatory inspectors and interacting with inspectors desirable • Demonstrated ability to work independently and deliver right first time results • Works under minimal direction • Work is guided by objectives of the department or assignment • Follows procedures • Refers to technical standards, principles, theories and precedents as needed • May set project time-frames and priorities based on project objectives and ongoing assignments. • Recognizes and escalates problems • Demonstrated leadership and communication skills • Auditing documentation and operation process • Demonstrated ability to interact with regulatory agencies
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Senior Associate QC - Microbiology (24/7 Shift)

Amgen Inc

Dublin
7 days ago
Dublin
7 days ago

Career Category

Quality

Job Description

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Specific Job Duties: 

  • Environmental Monitoring of Grade 8/9 Cleanrooms
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
  • Reading of Environmental Monitoring Plates
  • Bioburden testing of water & disinfectants
  • Writing technical reports
  • Water sampling
  • Testing of In Process samples such as Protein Concentration, Density & pH
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and perform validation and equipment qualification/verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
  • Approve lab results

Basic Qualifications 

  • Bachelors degree in a science discipline 
  • Biopharmaceutical QC experience in a microbiology lab 
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products 

Preferred Qualifications 

  • Experience working in an aseptic cleanroom performing Environmental Monitoring
  • Proficient in the use of LIMS & LMES
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products


Competencies 

  • Technically strong background in microbiology and aseptic manufacturing 
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage 
  • Flexibility – the EM role often encounters changing priorities on a daily basis
  • Problem solving skills
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction
  • Work is guided by objectives of the department or assignment
  • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies

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Microbiology Technician Job- Limerick

FRS Recruitment

Limerick, Limerick
1 day ago
Limerick, Limerick
1 day ago

Are you a Microbiology graduate with 1 years' GMP lab-based experience? A brand new role has been created for a Microbiology Technician to join the QC team of a leading Life Science company in Limerick . Candidates with previous GMP food and chemistry related backgrounds will also be considered, Full training provided .This company offers a very competitive salary along with a comprehensive range of benefits. Contact Felicity 086 7821714
This company offers a very competitive salary along with a comprehensive range of benefits to include:
  • A career development and training programme that allows employees to expand their skills and abilities to keep up with changing technology.
  • A good range of benefits - Pension, Life Assurance, Permanent Health Insurance, Bonus Scheme, Educational Assistance, Employee Assistance Programme, etc.

Duties:
  • Carry out basic testing
  • Testing including Bioburden and Endotoxin
  • Qualification of media
  • Testing of cleaning validation samples - water samples, biological indicators etc
  • Environmental monitoring
  • Standards and reagent preparation

Desired Skills and Experience:
· 1-2 years (minimum 1 year) GMP experience with a Degree qualification in a Science discipline
· Good team player, organised, accurate, have strong documentation skills
· Passionate about quality and customer service.
· Good communication skills both internally and externally.
For more information on this Microbiology Technician Job please contact Felicity Farrell on 086 7821714 day or evening.
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QC Microbiology Analyst (Shift) A0453

Independent Solutions

Dun Laoghaire, Dublin
14 days ago
Dun Laoghaire, Dublin
14 days ago
⦁ JobTitle:  
QC Microbiology Analyst (Shift) A0453

⦁ About the Company:
Our client, a multinational biopharmaceutical company, is seeking a QC Microbiology Analyst to join its expanding team in its Dun Laoghaire site, that includes a bioprocessing suite and laboratories. Make a difference in the lives of others, working at the forefront of biotechnology with the top minds in the field.

⦁ Duration of Job: 
12 months

⦁ Summary Objective
The QC Microbiology Analyst will be responsible for the following activities in QC including microbiological testing.

Note: This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

⦁ Job Duties:
• Environmental Monitoring of Grade 8/9 Cleanrooms.
• Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators.
• Reading of Environmental Monitoring Plates.
• Bioburden testing of water & disinfectants.
• Writing technical reports.
• Water sampling.
• Testing of In Process samples such as Protein Concentration, Density & pH.

Requirements

Requirements:
• Bachelors degree in a science discipline.
• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Experience working in an aseptic cleanroom performing Environmental Monitoring.
• Proficient in the use of LIMS & LMES.

⦁ Competencies:
• Technically strong background in microbiology and aseptic manufacturing.
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage.
• Flexibility – the EM role often encounters changing priorities on a daily basis.
• Problem solving skills.
• Experience with Regulatory inspectors and interacting with inspectors desirable.
• Demonstrated ability to work independently and deliver right first time results.
• Works under minimal direction.
• Work is guided by objectives of the department or assignment.
• Follows procedures.
• Refers to technical standards, principles, theories and precedents as needed.
• May set project timeframes and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems.
• Demonstrated leadership and communication skills.
• Auditing documentation and operation process.
• Demonstrated ability to interact with regulatory agencies.



**** No Visa Process ****

Benefits

Benefits of working with Independent Solutions

  • Benefit from Independent Solutions ethical principles!
  • We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency
  • While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team
  • We offer attractive rates - competitive margins compared to our competitors.
  • Payment on time and in full
  • We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
  • We work for you !


Requirements: • Bachelors degree in a science discipline. • Biopharmaceutical QC experience in a microbiology lab. • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. • Experience working in an aseptic cleanroom performing Environmental Monitoring. • Proficient in the use of LIMS & LMES. Competencies: • Technically strong background in microbiology and aseptic manufacturing. • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage. • Flexibility – the EM role often encounters changing priorities on a daily basis. • Problem-solving skills. • Experience with Regulatory inspectors and interacting with inspectors desirable. • Demonstrated ability to work independently and deliver right first time results. • Works under minimal direction. • Work is guided by objectives of the department or assignment. • Follows procedures. • Refers to technical standards, principles, theories and precedents as needed. • May set project timeframes and priorities based on project objectives and ongoing assignments. • Recognizes and escalates problems. • Demonstrated leadership and communication skills. • Auditing documentation and operation process. • Demonstrated ability to interact with regulatory agencies.
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Microbiology Analyst

BRIGHTWATER SELECTION (CORK) LIMITED

Limerick, Limerick
3 days ago
Limerick, Limerick
€27k - €35k Per Year
3 days ago
€27k - €35k Per Year

Are you an ambitious Microbiologist with at least 1 year of experience in a Pharma GMP laboratory?

Do you want to take the next step in your career?

My client is currently seeking good team players who are organised, accurate, have strong documentation skills, and are passionate about the quality of their work.

What's in it for you?

The opportunity to work at an innovation driven site where ground breaking medicines are manufactured for the global market. In this fast paced and diverse environment you will be challenged and learn and grow constantly.

Working on a shift cycle you will have a strong salary and benefits package with opportunities to progress also.

About the Job:

  • Performing routine and non-routine analysis, as requested by the Group Leader or customer representative.
  • Preparing and approving results for tests in which they have received the appropriate training and are deemed competent.
  • Notify immediately to the Group Leader or a customer representative, any anomalous or out of specification results.
  • Ensuring at all times that all documentation and laboratory records are up to date and of an appropriate standard.
  • Ensuring that all work carried out is approached “Right First Time” so as to avoid any re-work or errors.
  • Assisting in laboratory investigations as appropriate.

Skills Required:

  • GMP experience
  • LIMS experience
  • Investigation experience
  • Biological Indicators testing
  • Endotoxin Testing
  • Environmental Monitoring
  • Plate Reading
  • Plate Streaking /ID
  • Total Organic Testing
  • Ph and conductivity testing
  • Bioburden Testing

About You:

  • Degree in Microbiology
  • A Minimum of 1 years experience in a GMP Laboratory
  • Flexible, adaptable to changing priorities
  • Excellent communication and fluent English

For more on the role call Nigel on 021 2376302 or send your CV for consideration.

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Senior Tech - Microbiology

Edwards Lifesciences

Shannon
30+ days ago
Shannon
30+ days ago
Provide testing services in a laboratory environment.
Key Responsibilities:
• Perform routine and non-routine testing services using established procedures/protocols (e.g D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc)
• Collect environmental lab samples from multiple cleanrooms
• Perform data entry of routine and non-routine testing
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
• Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
• Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
• May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
• Initiate and support laboratory investigations and propose recommendations for manager view
• Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data
• Execute equipment and process validation protocols
• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
• Other incidental duties
Education and Experience:
Associate's Degree or equivalent in in a related science field, 3 years years experience of previous experience working in a laboratory environment Required
Additional Skills:
• Good written and verbal communication, interpersonal, and relationship building skills
• Able to read, comprehend, write and speak English
• Good computer skills, including usage of MS Office; Analytical Equipment System (e.g ChemStation, Empower) preferred
• Substantial knowledge of laboratory processes
• Substantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
• Substantial knowledge in mathematics, e.g., decimals and percentages
• Ability to write technical documents
• Good knowledge with ISO microbiological sterilization documents if applicable
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work in a team environment
• Ability to provide feedback in a professional, direct, and tactful manner
• Ability to represent the organization to outside contacts, i.e., vendors
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Microbiologist

Charles River Laboratories

Ballina
9 days ago
Ballina
9 days ago
Microbiologist
Req ID: 95933
Location:
Ballina, IE, F26D786
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
We are seeking an experienced Microbiologist for our Biologics Department located inBallina, Co. Mayo.You shall be reporting to the MicrobiologyDepartment Manager.
The main duties & responsibilities shall be;
+ GMP Compliance.
+ Perform Endotoxin testing, Sterility testing, Efficacy of Antimicrobial Effectiveness test, Environmental Monitoring, Water testing, Microbial Limit testing, Bioburden testing.
+ Qualification/Validation of test methods
+ Carry out Quality Control Checks
+ Assist in Laboratory Investigations
+ Trending of Laboratory Data
+ Update SOP's as required
+ Provides training to other members of the Microbiology team as required.
+ Proactively identifies and implements Laboratory process improvements.
The following are minimum requirements related to the Laboratory Technician position;
+ BSc. in a relevant science discipline
+ Some hands on work experience in a regulated Microbiology Laboratory would be beneficial.
+ GMP experience
+ Excellent communication skills, both verbal and written
+ Collaboration and Teamwork. Maintains the highest standards of ethical behavior
+ Results and performance driven
+ Strong analytical ability and associated problem solving
+ Good time management and attention to detail
+ Knowledge and proficient in the use of Word, Excel etc
+ Experience in Mycoplasma testing would be an advantage
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.

Posted

30+ days ago

Description

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

TRIO (Translational Research in Oncology) is a not-for-profit academic clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted therapeutic concepts in the clinical trial setting. We are committed to providing treatments of the future to the world of today.

We are looking for Clinical Research Associate Consultants (contract/freelance) to join our international team, home-based in Ireland. Our CRAs play a pivotal role in moving our important research forward and helping to save cancer patients’ lives all over the world.

TRIO’s head office is in Edmonton, Alberta with operations throughout Canada, the USA, France and Uruguay. The main objective of the Monitoring Resources team is to effectively monitor TRIO’s clinical trials according to contractual obligations and project deadlines according to the sponsor protocol and in compliance with the appropriate SOPs.

Reporting to a Monitoring Resources Coordinator, a CRA is responsible for the following:

  • Conducting site visits, including pre-study, initiation, monitoring and termination;
  • Confirming adherence to all FDA, ICH-GCP and local regulations;
  • Ensuring the completion and collection of regulatory documents;
  • Performing data verification of source documents;
  • Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
  • Participating in budget negotiation and follow-up where applicable;
  • Assisting with data validation and query resolution;
  • Mentoring junior team members as required.

Qualifications:

  • A minimum of 2 yearsof monitoringexperience in oncology trials
  • An advanced level of oncology knowledge
  • Completion of a science-related Bachelor’s degree
  • Excellentknowledgeofmedicalterminologyandclinicalmonitoringprocess
  • StrongICH-GCPsknowledge
  • Experiencewith clinical trial information systems
  • Ability to travel up to 60% on average

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Source: Translational Research in Oncology