Pharmaceutical Quality Assurance Analyst



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Branch Information

Swiftwater, PA - (USA) 1 Discovery Drive PA Swiftwater , PA 18370

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Job Description

Site Quality Operations (SQO) department is a service unit supporting the Clinical Supplies organization. It is responsible for providing Quality Assurance activities and services to the Clinical Supplies Platform in maintaining compliance with global and regional ICH/GCP and cGMP requirements.

Monitor and continuously improve the Quality system by evaluating supporting documentation to ensure compliance to cGMP, Industry standards and other applicable regulations. Take appropriate actions to correct any deficiencies found.

Perform inspection and release for investigational product labeling, investigational and commercial product and packaging components against approved specifications.

Perform routine inspections of retain samples and maintain up to date inventory of retain samples.

Review and approve labeling design and final proofs as well as printed packaging materials to ensure compliance with FDA and ICH regulations.

Perform batch record reviews for all Investigational Product labeled and packaged at Northborough (or contractor) as well as release for incoming product, components and labeling and packaging materials as needed.

Provide input, review and approve documentation for the labeling/packaging operations at contract vendors. Perform batch record review and release for these operations to ensure compliance to cGMP and other applicable regulations.

Assist in internal audits, as needed, and raise CAPAs in Trackwise or equivalent system, as needed.

Provide support and assist in managing Quality eSystems to ensure compliance to established timelines for deviations, CAPAs, investigations, OOS, etc.

Provide Quality support and services to Clinical Supplies, as needed, to ensure compliance to cGMP and other applicable regulations.

Complete other duties, tasks and projects as required.