External QC Associate IIApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 6+ months
Job Summary: The individual in this role will support External QC testing for outsourced late phase clinical and commercial manufacturing. They will support QC administrative functions with contract testing laboratories and contract manufacturing organizations.
- Assist in testing program support at contract manufacturing organizations and contract laboratories for raw materials, drug substance and drug product
- Participate in cross-functional project teams to track Quality Control related activities
- Perform administrative activities such as review of forms and spreadsheets, tracking of sample status, and compilation of metrics
- Perform data entry in GMP LIMS systems
- Bachelor’s degree in a relevant scientific discipline with at least 2 or more years in a cGMP Quality Control Lab or Quality Control support function
- Experience working in a fast-paced laboratory at a biotech/pharmaceutical company
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations is preferred
- Strong written, oral communication and organizational skills required
- Ability to collaborate effectively with peers, supervisors, and colleagues at contract organizations
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