Quality Assurance Senior Associate, Biotech (JP7195)
Thousand Oaks, CA.
Contract, various shifts (days, swings, and night shifts)
Cell Bank and Drug Substance Supply PQA
24+ months (with likely extensions)
Job Posting Date:
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
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.
Why is the Position Open?
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Bachelor's Degree in a science field required
- Must have 2-3 years experience in Drug Substance Manufacturing (Biotech)
- 2-3 years experience in Quality Assurance/Manufacturing/engineering
- 1-2 years experience in batch record review
Electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs.
Employee Value Proposition:
Great opportunity to get into a leading biotech company
No direct experience in biotechnology
No undergraduate degree
No GDP/GMP experience
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to email@example.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.