- Title: QA Technical Operations Lead
- Code: RCI-30949-1
- Location: Devens Massachusetts (MA) 01434
- Posted Date: 03/24/2020
- Duration: 6 Months
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- Name:Pramod Rajput
- Email: Pramod.email@example.com
- Phone: 908-704-8843 ✖ 217
- May provide Quality support of technical services programs.
- Provides quality support to Devens Site through quality review and approval of investigations and change controls.
- Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
- Assures consistent, effective use of the site change control system for all change requests.
- Ensures supporting documentation and change deliverables meet external regulatory and internal WWQC guidelines and requirements.
- Represents QA in cross-functional meetings
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
- Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred
- Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic systems including any of the following:
- Past experience where one was required to work in a team based environment with a diverse group of people.
- SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.
- Excellent writing and oral communication skills are required.