What are the responsibilities and job description for the Clinical Supplies Quality Assurance Specialist 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
The mission of Quality Assurance is to : safeguard the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. Every breakthrough we create has the potential to build a healthier, more hopeful future for people everywhere. Patients are our purpose – that’s why we pursue the best science in our inventions and everything we do. This position is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex / niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures / Collaborations, Independent Investigator-Initiated Studies, etc. Responsibilities may include but are not limited to the following :
- Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies / procedures of our Company and compliance with all governing regulations
- Coordinate and / or support the preparation of procedures, processes and quality improvements
- Completing projects to improve the performance of our processes, including continuous process improvements, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times
- Assists in the coordination of significant quality events including fact finding, investigation support
- Collaboration across IPT functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
- Actively using and championing the use of Lean Six Sigma (LSS) and client specific Production System tools, both in problem solving and day-to-day operational activities.
Qualifications
EDUCATION :
REQUIRED :
PREFERRED :
Additional Information
Position is Full Time, Monday-Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of West Point , PA are encouraged to apply.
What we offer :
Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
