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.
EDUCATION:
- Bachelor's Degree or higher in engineering, science, or related discipline from an accredited college/university
REQUIRED:
- Minimum 2 years of experience in the Pharmaceutical or equivalent industryGood Manufacturing Practice (GMP) related field including Technical,Engineering, Quality or Operations.
- Familiarity with batch disposition activities
- Strong problem-solving, collaboration, and written and oral communication skills
- Ability to independently manage multiple priorities
- Demonstrated teamwork skills and ability to work independently.
- Basic understanding of the use and maintenance for Microsoft applications (suchas MS Excel, Outlook, and/or MS Access)
- Attention to detail, flexibility and an awareness of production and quality control problems.
PREFERRED:
- Proven ability to work independently and collaborate effectively as part of a team.
- Strong organizational, interpersonal, writing, and time management skills.
- Computer skills; knowledge and competency in ERP/MES, Trackwise, SAP
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:
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
