Quality Assurance Associate
1 week ago
**_
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services.
It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies._**
_ In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories.
Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
__ In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years._
_ ____________________________________
- Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its stateoftheart organization, with continued investments in its people, modern facilities, equipment, and instrumentation._
Job Description:
The Quality Assurance Associate will play a key role in ensuring Eurofins CDMO Alphora Inc.'s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious pharmaceutical APIs on behalf of our clients and their patients.
This is an excellent opportunity to obtain experience in a pharmaceutical manufacturing setting and to work on projects related to all phases of the pharmaceutical product life cycle.
This role will be engaging and challenging for an individual that has a desire to learn and thrives in a high-paced environment with a variety of new projects and unique challenges to overcome.
KEY DUTIES AND RESPONSIBILITIES:
- Liaise with production, quality control, and analytical services staff
- Review quality control lab data for raw materials, inprocess controls, intermediates and APIs for accuracy, completeness and compliance to CGMP or other applicable regulatory standards
- Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established CGMP or other regulatory standards
- Release intermediate and API batches that satisfy quality requirements
- Review analytical data and protocols for standard qualification, stability, method qualification, and method validation protocols for accuracy, completeness and compliance to GLP or other regulatory standards
- Provide production support including equipment and line clearances
- Review and approve laboratory and batch summary reports
- Review and approve quality documents including but not limited to sampling analysis and labeling forms, deviations/amendments (planned deviations), OOS/OOT/OOC investigations, logbooks, cleaning records, and temperature monitoring data
- Perform oversight of final product packaging operations
- Review and input on Standard Operating Procedures (SOPs)
- Review and feedback on deviation assessments
- Conduct root cause investigations related to deviations, out of specifications, and out of calibrations and evaluate related impact assessments and proposed Corrective Actions/Preventive Actions
- Assist in the development and establishment of suitable Corrective Actions/Preventive Actions (CAPAs) based on investigation outcomes
- Review change controls and QC specifications on a limited basis
- Assist in preparation for internal, customer and regulatory agency audits
- Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities
- Participate in opportunities to develop knowledge of CGMP and business operations
- Other duties as assigned by the Quality Assurance Manager
Qualifications:
- BSc; specialization in chemistry is preferred
- 25 years o
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