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Quality Assurance Senior Associate, Biotech DS (JP7369)

Thousand Oaks, California · Biotech/Pharmaceutical
Job Title:  Quality Assurance Senior Associate, Biotech DS (JP7369)
Location: Thousand Oaks, CA.
Employment Type:  Contract, various shifts (days, swings, and night shifts)
Business Unit:  Drug Substance Quality Assurance
Duration: 18+ months (with likely extensions)
Rate: $28-32/Hr (W2) DOE
Job Posting Date: 06/16/2020
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Please note that Schedule will need to be flexible to support 24/7 operations. This includes Day and Night Shifts. 10-12 hours shift schedules, rotating. 4 different shifts.
Job Description:
This role supports Quality Assurance department under the Operations organization providing daily oversight of Drug Substance Manufacturing production activities.

Under general supervision, the role provides support and compliance oversight to Manufacturing, Facilities, Engineering, Supply Chain, and other support staff in the execution of their processes, procedures, and use of quality systems.

Duties include electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs.

The candidate will be required to evaluate compliance issues, provide recommendations, and assure progress to completion. The candidate will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals. Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.

Schedule will need to be flexible to support 24/7 operations. This includes days, swings, and night shifts. 
Top Must-Have Skill Sets:
  • Experience with batch record review
  • Experience with document review/approval
  • Strong communication skills
Day to Day Responsibilities:
  • Batch Record Review
  • Deviation Review
    Document Review
  • Work Order Review
  • Maintain a safe and inspection ready facility
Employee Value Proposition:
Great opportunity to get into a leading biotech company
Red Flags:
  • Poor communication skills
  • No experience in a drug substance facility
  • Must have college degree
  • Must support 24/7 operations
Interview process:
Phone screen followed by Skype Video
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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