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Specialist Quality Assurance

Woburn, MA
Top 3 Must Have Skill Sets: 

GMP experience
Quality over site of QC or Manufacturing
Pharma or Biotech experience

Day to Day Responsibilities: 

Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured at contract sites manufacturing on behalf of Amgen. Primary responsibilities of this position include translating technical documents such as batch records, investigations, change controls and complaints documentation into English. Some of these activities include communicating with the Amgen quality person stationed at the contract manufacturer facility. Specific language requirements will be noted in the additional comments section.; Skills: ; knowledge of process and faculty equipment, and the ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry;

"This posting is for Contingent Worker, not an FTE"

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