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Quality Specialist
4 weeks ago
Title: Quality Specialist
Location: Allentown, PA
Duration: 12 Months
Pay: $45 ph. on W2
What will you do?
- Uses sound knowledge of regulations, authorizations, products, and processes, coupled with the experience of manufacturing and packaging, and its business requirements to thoroughly verify all aspects of the batch safety, identity, strength, purity, and quality. Collaborates with Clients to fully comprehend their Batch review and release requirements and the regulatory obligations which their company must fulfill.
- Carries out a full analysis of all inputs into the Batch creation process. Considers all factors that may affect the quality of the batch in view, such as environmental monitoring, analytical results, calibration, validation, preventative maintenance records, and investigations to include the impact of ‘split-site’ or ‘multiple-site’ processing as part of the final batch release criterion.
- Proactively identifies batch review concerns, promptly communicates and raises (when appropriate) issues of batch release non-compliance, Out-of-Specification (OOS), or potential failure to Quality Management. Recommends steps to resolution, when appropriate.
- Prioritizes batch record reviews and Client releases to achieve objectives and deliver industry quality results within a
- Maintains both internal and external customer service expectations with clear, concise, and expedited communication.
- Communicates delays promptly to affected internal parties.
- Represents QA and provides support to internal team meetings, as needed.
Required Experience
- Bachelor's Degree is required (Life Science preferred); advanced degree is a plus
- 3-5 years of pharmaceutical or medical device experience in a GMP environment, preferably in Quality. With 3 years of finished goods commercial batch record release experience strongly preferred.
- Must be detail-minded to detect errors or deficiencies on batch records with the ability to use good judgment in discerning if documentation accurately and completely reflects packaging operations.
- Experience with Quality Systems (change control, deviations, complaint management, eDMS), with a desired knowledge of SAP, TrackWise and Documentum.
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