Job Description

Our client a, patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases seeking a QA Person In plant to join their growing team.

Responsibilities:

• Perform batch record review of investigational products manufactured at CMO partners.
• Perform QA/client review for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.
• On-site oversight of CMO operations as needed.
• Ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sites
• Support Manufacturing to collect and monitor key performance indicators of CMO and contract/external laboratories.
• Review, maintain, and execute against Quality Agreements with the Supplier/CMO network.
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.

Skills:

• 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience in the field of cell therapies preferred.
• Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs
• Ability to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.
• Demonstrated ability to manage multiple complex relationships within a CMO network
• Experience with electronic Quality Management Systems
• Experience in conducting or hosting Quality and/or Health Authority audits.

Education:

·Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology

Job Tags

Similar Jobs