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Quality - QA Associate
Location: US-MA-Ayer
Jobcode: d2df031fcab6a09c6adaeaf85741d4de-122020
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- 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.
- 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.
- 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.
Requirements:
- 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
Rangam Consultants Inc.
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