- Title: QA Associate
- Code: RCI-6978
- Location: Thousand Oaks California (CA) 91320
- Posted Date: 02/13/2020
- Duration: 24 Months
- Name:Mangesh Kanade
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 260
Schedule will need to be flexible to support 24/7 operations, this includes days, swings, and night shifts.
This role supports Quality Assurance department under the Operations organization providing daily oversight of Drug Substance Manufacturing production activities.
- 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
- Evaluate compliance issues, provide recommendations, and assure progress to completion
- Represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals
- Must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.
- Electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs
- 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