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Quality Assurance Senior Associate - (JP9365)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Quality Assurance Senior Associate - (JP9365)
Location: West Greenwich, RI.  02817
Employment Type:  Contract
Business Unit: ARI Quality Operations
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Notes: Will work SAT/SUN/MON and hours will vary***Onsite in Rhode Island
Posting Date: 11/8/2021

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

Job Description:
  • Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Deviations
  • Oversee and provide guidance during on-the-floor analytical testing.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alerts senior management of quality, compliance, supply and safety risks.
  • Completes required assigned training to permit execution of required tasks.

Why is the Position Open?
Backfill for someone who is converting to full time.

Top Must Have Skills:
Experience in a GMP environment, Quality Assurance experience, audit experience.

Day to Day Responsibilities:
Successfully oversee manufacturing operations through purposeful presence, perform electronic batch record review on the manufacturing floor, coach staff in Good Documentation Principles.

Employee Value Proposition:
The chance to gain and expand work experience with a team of professionals, as well as the potential to convert to permanent down the road.

Interview process:
Video Skype Panel 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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