QA Specialist (Technical Specifications Specialist)

Job Details:

• Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
• Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers).
• Interface cross-functionally within Amgen (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers. Draft specifications based on raw material attributes, where they are used in the Amgen process and how they should be controlled.
• Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
• Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.

Qualifications:

• Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering);
• Advanced Degree a plus
• Background in GMP operations and manufacturing processes.
• Strong technical background (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
• Change Control owner (managing revisions to specifications)