What are the responsibilities and job description for the Quality Control Molecular Scientist - ELISA position at Eurofins USA PSS Insourcing Solutions?
Job Description
Job Description
Company Description
The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
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.
If you’re looking for a rewarding career, a place to call home, apply with us today!
Job Description
General Description :
Perform testing in support of product manufacturing, employing manual and automated analytical equipment. Provide direct support of Quality Control analytical processes, test procedures, qualifications, validations, assay troubleshooting, equipment upkeep, logbook review, and inventory control.
Job Responsibilities :
- Execute Analytical Test Methods for in-process samples, bulk intermediate (drug substance), final drug product, and raw materials release, as well as stability testing.
- Primary testing responsibility will be conducting ELISA testing to support assays such as Residual p24, COL7 / Lam332, BSA, and Trypsin assays. However, cross-training in cell culture and other analytical methods will be required (e.g. qPCR, flow cytometry platforms).
- Coordinate, schedule, and execute testing based on manufacturing schedules.
- Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.
- Review Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.
- Troubleshoot and analyze nonconforming data.
- Perform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.
- Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.
- Maintain laboratory housekeeping including organization, cleanliness, and logbooks.
- Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.
- Author and / or execute protocols and generate technical reports.
- Author and manage change controls.
- Perform equipment standardizations and qualification, as necessary.
- Perform training of other employees.
- Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
Qualifications
Basic Minimum Qualifications :
Additional Information
Position is Full Time, First Shift - some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton, PA are encouraged to apply.
What we offer :
Eurofins USA PSS Insourcing Solutions is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
