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Quality Assurance Senior Specialist – (JP10064)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title:  Quality Assurance Senior Specialist – (JP10030)
Location: West Greenwich, RI.  02817
Employment Type:  Contract
Business Unit: n/a
Duration: 8+ months (with likely extensions)
Notes:  Onsite position at ARI. Rotating night shift.

Posting Date:  04/12/2022

3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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.

Basic Qualifications:
  • 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.
  • Written and spoken fluency required in specific language needed

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Ability to follow direction in a GMP environment
  • Capable of working flexible hours (night shift)
  • Capable of following written instructions for GMP processes
  • Experience with quality production and documentation
  • Worker will be adhering to strict safety protocol.

Day to Day Responsibilities:
To be able to learn our current software system used to review records, and that the worker is capable of understanding the function of GMP facility.

Employee Value Proposition:
Growth/ opportunity.

Red Flags:
  • Unable to follow direction
  • Lack of experience in GMP concepts
  • Lack of interest to learn

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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