Quality Specialist for Biologic Programs

QUALITY SPECIALIST FOR BIOLOGIC PROGRAMS NORTH WALES, PA Required Skills:

• B.S. in Biology, Biochemistry, Molecular Biology, or related biological science.
• 3+ years of laboratory experience.
• Demonstrated teamwork skills and ability to work independently.
• Strong technical knowledge and high level of technical performance.
• Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation with an emphasis on molecular and analytical techniques.
• GMP experience.
• Previous technical and/or analytical troubleshooting experience in biologics development, and/or quality site experience.
• Proficiency in molecular biology techniques and/or biochemistry techniques.
• Experience in the following assays: ELISA, HPLC, CE.
• Ability to work effectively in a team environment.
• Technical / analytical data comprehension.
• Judgement, organization, and project management abilities.

• The Quality Specialist Contractor will be responsible for supporting the large molecule biologic critical reagents programs.
• This position requires hands-on laboratory experience in molecular biology and analytical techniques for biologic critical reagents, such as reference standards, positive controls, and other critical materials.
• Under guidance, the incumbent will support the lifecycle of biologic critical reagents, from generation and testing to inventory and shipping.
• All work will be conducted to the highest quality and conform to GMP and regulatory expectations.