qa analyst jobs

Near waterford
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6 jobs found for qa analyst jobs Near waterford

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QC/QA Analyst-Data Review Job

FRS Recruitment

Waterford, Waterford
Today
Waterford, Waterford
Today

QC DATA REVIEW ANALYST JOB-CHEMISTRY-part-time hours can be facilitated
*I currently have a fantastic opportunity for a QC Analyst looking to move into a Data review role. .
If you are an experienced QC Analyst/Chemist with 3-4 years' experience in a GMP environment and looking to move away from bench testing role , then this Data Review Analyst -Chemistry Job is an excellent opportunity not to be missed .
This is an exciting chance to join an leading pharmaceutical company in Waterford that can offer you excellent opportunities for progression and development. In this Data Review Analyst job you'll be working in an amazing , modern facility with cutting edge technology and in a dynamic and supportive working environment.
*This is a permanent position with a very attractive salary package*
Duties and Responsibilities
  • Check raw data and ensure all pertinent procedures (SOPs) and analytical methods have been followed when analysing products and calculating results.
  • Review documentation related to analyses (lab book, reference standard preparation logbook) in regard to good documentation practices, calculation and reporting of results.
  • Assess the calibration status of instruments and other tools used to perform the testing.
  • Declare and document any deviation using current quality system procedures.
  • Ensure compliance and quality of analysis in respect to analytical methods and current specifications for raw materials and finished products.
  • Document and investigate any out-of-specification (OOS) results according to current procedure.
  • Maintain an up to date OOS list, review any pending items, and close investigations on time.
  • Close laboratory reports and proceed to the release of raw materials.
  • Issue certificates of analysis for finished products
  • Work closely with the Laboratory Supervisor to maintain timelines, inform of any deviation or OOS results that may impact delivery deadlines.
  • Participate in archiving the raw data, certificates of analysis and investigation reports.
  • Drive CAPA and other action item follow up.

Requirements
  • Bachelor's degree in Chemistry, Biochemistry or related science.
  • Minimum of 3-4 years of quality control analytical chemistry in a GMP environment(essential)
  • Strong knowledge and understanding of cGMP and cGLP, data integrity principles, good documentation practices and laboratory investigations.
  • Knowledge of analytical techniques, Empower 3 software and general chemistry testing for pharmaceuticals
  • Strong leadership, initiative, autonomy, problem solving, organisation, results-orientation, communication and interpersonal skills.
  • Courage to inform about any quality event observed or any delay that impacts the established timeline.
  • Familiarity with Quality Management Software i.e. Trackwise or other

Once your CV has been received, I will give you a call to chat about the role in more detail and what this Data Review Analyst job could offer you!
If you are interested in hearing more about this unique , Data Review Analyst job opportunity please contact Felicity Farrell @FRS Recruitment on or connect with me on LinkedIn
Applicants are advised to APPLY NOW to avoid disappointment.
You may have also searched for Job Titles: Technical Writer Job, Chemist Job Waterford, Scientific Technical Writer Job Waterford, Lab Analyst job Waterford ,QC analyst job Waterford , Chemist job Waterford, QC chemist job, QC Analyst job, Laboratory Technician job Waterford , QC Analyst Job, QC Analyst Job , Chemist Job, QC chemist, QC Analyst Job, Laboratory Technician Job
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Quality Engineering Lead

FRS Recruitment

Waterford, Waterford
Today
Waterford, Waterford
Today

Position Summary:
The Quality Engineer Lead assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Assists in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
Key Responsibilities
  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate.
  • Individual with an experienced background in sterilisation, automation, equipment/software validation.
  • Individual with an experienced background in manufacturing within controlled environments.
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained).
  • Individual shall have exposure & involvement in supporting the CAPA system.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.


Requirements
  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
  • 5 years' experience in a Quality Engineering role in a regulated environment.
  • Fully competent in Quality Management Standards.
  • People Management experience

Skills/Attributes:

  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
  • Excellent organisation, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Solution driven with emphasis on performance and results.

Organization Linkages:
  • Reports to Site Quality Lead
  • Plant wide Teams and Managers.
  • Customers, Contractors, Vendors and Suppliers.
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Senior Quality Engineer(Micro)

Integer

New Ross
30+ days ago
New Ross
30+ days ago
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
+ Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
+ Provide direction and training to other staff members performing duties in the microbiology area.
+ Develop, validate and maintain sterilization systems for Integer products. Conduct sterile validations and adoptions for new products. Coordinate and train staff to assure that all functions involved in completing the production sterile runs are carried out.
+ Develop and perform testing to ensure product safety and meet biocompatibility requirements of FDA, ISO, Japanese Ministry of Health and other regulatory agencies.
+ Develop and coordinate the cleanliness and contamination control programs for Integer manufacturing areas. Coordinate environmental monitoring on all cleanrooms. Provide training and guidance on regulations for cleanroom operations. Provide guidance on water quality management.
+ Select and audit contract sterilizer and testing laboratories.
+ Primary customer and regulatory body contact on sterilization, cleanliness policies and biocompatibility issues.
+ Complete protocols, final reports, and validations related to sterilization, biocompatibility and environmental monitoring.
+ Provide guidance and leadership to product development, production and product transfer teams on biocompatibility and sterilization requirements, as well as environmental impacts of new product introductions and production line layout changes.
+ Apply continuous improvement/lean concepts to identify and eliminate non-valued added tasks and/or activities.
+ Apply problem solving methodologies 8D, PDCA, DMAIC to identify root cause and create and implement corrective and preventive actions.
+ Performs other duties as required.
+ Knowledge & Skills:Special Skills:
+ Ability to apply advanced skills in microbiology and develop new methods to solve complex problems.
+ Ability to exercise independent judgement in developing methods, techniques and evaluation criteria
+ Skilled in multi-tasking and prioritizing.
+ Excellent written and verbal communication skills. Good presentation skills.
+ Specialized Knowledge:
+ General knowledge of GLP, GMP and QSR.
+ Working Knowledge of Medical Device Regulatory requirements including FDA, ISO and PMDA Ministry of Health (Japan).
+ Knowledge of scientific theories and methods pertaining to bioburden, LAL and water testing. Ability to interpret relation of bacterial identifications.
+ Knowledge of the methods of biocompatibility testing and the ability to interpret the data in relationship to current industry guidance.
+ Knowledge of EO sterilization process and requirements to validate and maintain a sterile cycle.
+ Other: Physical demands include equal amounts of sitting, standing and walking (including stairs and between buildings). High level of computer keyboard typing and computer screen viewing. Lift boxes up to 40 lbs. Use problem-solving techniques, high degree of attention to detail, work effectively on teams and communicate effectively with and lead people inside and outside the department.
+ Education & Experience:Minimum Education: Bachelor’s degree in one or more of the following disciplines: Biology (Biological Sciences), Microbiology, Molecular Cell Biology (MCB), Biochemistry or Chemistry. Alternatively two years of experience in a related field may be substituted for every year of education. Minimum Experience:
+ Five (5) to eight (8) years experience in the medical device manufacturing industry and at least (3) years’ experience in microbiology.
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at
716-759-5739.
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Quality Engineer III

Integer

New Ross
30+ days ago
New Ross
30+ days ago
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
JOB SUMMARY
The Senior Quality Engineer will primarily be responsible for developing and maintaining all quality systems and monitoring production process for compliance to implemented process controls. Under minimal direction, manages Quality projects that may cover multiple sites. Duties will involve coordination, and scheduling of program or project activities. Assignments are broad in scope with the opportunity for the use of independent judgment. Essential Quality engineering skills are required.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job-related tasks which may not be specific to this position profile.
POSITION REQUIREMENTS
Interfaces directly and regularly with customers (internal and external) staff. Often is included in critical business discussions with customers to bring deep insight to a problem or opportunity and establish a high level of credibility for Integer through demonstrated program management knowledge and expertise.
Proactively manage the risk associated with projects so that Integer’s and the customer’s business objectives are achieved. Minimize the uncertainties associated with projects relative to scope changes, customer expectations, business issues and other intangibles to enable successful completion of projects.
Involve and coordinate the input of all key functional groups and contributors to the proposed work plan.
Follows and develops Quality and Regulatory requirements including Integer’s policies, procedures, and appropriate regulatory requirements and have the standard Quality engineering skill set as outlined below.
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer tools & templates were available.
As outlined above must have standard Quality engineering skills as outlined below:
1. Compliance with all Regulatory Standards, this includes:
Completion of internal audits to: ISO 13485 FDA QSR ISO 14000
b. Participation in Corporate auditing programs
c. Ensuring continued compliance with DMR
2. Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
Participation in validation protocol development Overseeing completion of validation or validation samples Supporting the engineering function to ensure compliance to related element of quality system
3. Liase with engineering departments on new product development projects to ensure;
All quality control requirements for non standard product are clearly understood All product samples for new product development qualification are inspected Relevant process controls are documented and transferred to production and suitably implemented with necessary training.
4. Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
Trend analysis of data from the controls
Potential improvements for review with engineering based on the trends
Areas for Improvement to senior management
Review and propose changes to sampling plans based on trend analysis and changes to the system
5. Maintenance of customer concerns handling system in a timely manner including
Returned product analysis Organisation, filing and reporting of customer concerns
Ensure the requirements of the Electronic Documentation Management system
are understood and implemented at all levels of the organization.
Accountable to monitor manufacturing activities, measure significant process characteristics and analyse variation in order to detect and reduce waste
Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements. Play a leadership role in encouraging the Company to achieve world class standards, above all by setting your own high professional standards as an example.
SKILLS AND KNOWLEDGE:
Ability to communicate and work with people inside and outside the department.
Excellent communicator: verbal, written and presentation skills.
Ability to train and lead assigned employees.
Ability to co-ordinate, plan and organise in a timely manner.
Knowledge of engineering theories and methods.
Rigorous attention to detail.
Ability to use Microsoft Office Suite (Excel, Project, Word, PowerPoint at a minimum) and ability to use / learn Oracle as the company ERP system (preferably Oracle)
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
+ Demonstrate leadership in project management
+ Engineering, Science or Project Management Degree preferably with Quality Engineering included
+ Qualified systems lead auditor
+ Program Management certification or number of years experience
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at
716-759-5739.
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Job Type

Full Time

Posted

Today

Description


QC DATA REVIEW ANALYST JOB-CHEMISTRY-part-time hours can be facilitated

*I currently have a fantastic opportunity for a QC Analyst looking to move into a Data review role. .

If you are an experienced QC Analyst/Chemist with 3-4 years' experience in a GMP environment and looking to move away from bench testing role , then this Data Review Analyst -Chemistry Job is an excellent opportunity not to be missed .

This is an exciting chance to join an leading pharmaceutical company in Waterford that can offer you excellent opportunities for progression and development. In this Data Review Analyst job you'll be working in an amazing , modern facility with cutting edge technology and in a dynamic and supportive working environment.

*This is a permanent position with a very attractive salary package*

Duties and Responsibilities
  • Check raw data and ensure all pertinent procedures (SOPs) and analytical methods have been followed when analysing products and calculating results.
  • Review documentation related to analyses (lab book, reference standard preparation logbook) in regard to good documentation practices, calculation and reporting of results.
  • Assess the calibration status of instruments and other tools used to perform the testing.
  • Declare and document any deviation using current quality system procedures.
  • Ensure compliance and quality of analysis in respect to analytical methods and current specifications for raw materials and finished products.
  • Document and investigate any out-of-specification (OOS) results according to current procedure.
  • Maintain an up to date OOS list, review any pending items, and close investigations on time.
  • Close laboratory reports and proceed to the release of raw materials.
  • Issue certificates of analysis for finished products
  • Work closely with the Laboratory Supervisor to maintain timelines, inform of any deviation or OOS results that may impact delivery deadlines.
  • Participate in archiving the raw data, certificates of analysis and investigation reports.
  • Drive CAPA and other action item follow up.

Requirements
  • Bachelor's degree in Chemistry, Biochemistry or related science.
  • Minimum of 3-4 years of quality control analytical chemistry in a GMP environment(essential)
  • Strong knowledge and understanding of cGMP and cGLP, data integrity principles, good documentation practices and laboratory investigations.
  • Knowledge of analytical techniques, Empower 3 software and general chemistry testing for pharmaceuticals
  • Strong leadership, initiative, autonomy, problem solving, organisation, results-orientation, communication and interpersonal skills.
  • Courage to inform about any quality event observed or any delay that impacts the established timeline.
  • Familiarity with Quality Management Software i.e. Trackwise or other

Once your CV has been received, I will give you a call to chat about the role in more detail and what this Data Review Analyst job could offer you!

If you are interested in hearing more about this unique , Data Review Analyst job opportunity please contact Felicity Farrell @FRS Recruitment on or connect with me on LinkedIn

Applicants are advised to APPLY NOW to avoid disappointment.

You may have also searched for Job Titles: Technical Writer Job, Chemist Job Waterford, Scientific Technical Writer Job Waterford, Lab Analyst job Waterford ,QC analyst job Waterford , Chemist job Waterford, QC chemist job, QC Analyst job, Laboratory Technician job Waterford , QC Analyst Job, QC Analyst Job , Chemist Job, QC chemist, QC Analyst Job, Laboratory Technician Job