- Title: QA Associate
- Code: RCI-32370-1
- Location: Devens Massachusetts (MA) 01434
- Posted Date: 07/31/2020
- Duration: 6 Months
- Name:Vishal Trivedi
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 435
This position will be supporting 24x7 Operations. The primary shift will be one of four rotating 12-hour shifts (5AM to 5PM or 5PM to 5AM, which is alternating 2-3 days on/off).
The position will start as a M-F during onboarding period, and then transition within ~6 weeks to one of the four rotating shifts
- Maintains shop floor quality presence; releases raw materials, in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews.
- Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines.
- May assist in preparing for a hosting of regulatory and customer audits.
- Provides support to manufacturing including quality approval of investigations, participation in change control and area walkthroughs.
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
- Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
- Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
- Samples, inspects and releases consumable and raw materials per specifications.
- Drafts and reviews specifications and SOPs. Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing.
- May provide guidance to less experienced staff.
- Provides QC support including lab inspections, method qualification, method technology transfer, LIMS and Smart Lab support, etc.
- Strong communication skills and demonstrated ability to influence stakeholders is required.
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is preferred.
- B.S., in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent is preferred.
- 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of SAP, LIMS, Delta V, Maximo, Syncade are a plus