Quality Assurance Specialist
Confidential - Norristown, PA
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QA Specialist - East Norriton, PAGeneral Company DescriptionMy client is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.Position Summary & RoleThe Quality Assurance Specialist will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing. Job ResponsibilitiesWork collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.Maintain a presence of Quality Assurance on the manufacturing floor during GMP runs to ensure compliance to GMPs.Escalate any events occurring on the manufacturing floor to Management.Review deviations, change controls and/or CAPAs, as needed.Review batches manufactured at the East Norriton facility, as needed.Author and review technical documents including but not limited to SOPs, various quality reports.Perform Facility change overs and Line clearances.Issuance of product labels, as needed.Release of GMP materials utilized in the manufacturing process, as needed.Preferred Experience, Education & QualificationsB.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).3-7 years relevant life sciences quality experience within quality and/or quality related functions.Demonstrated track record with the successful support of GMP manufacturing and testing environments.Demonstrated quality experience and the ability to collaborate with and effectively influence others. Demonstrate experience with gowning and following aseptic behaviors.Specific experience with aseptic, cell therapy and/or viral vector manufacturing strongly preferred.Familiarity with electronic quality systems/software applications.Familiarity with laboratory and manufacturing execution systems.Working knowledge of GLP/GCP and GxP Regulatory requirements.Experience in preparation and participation in regulatory authority plant/site inspections.Experience supporting biologics manufacturing preferred.
Created: 2024-09-26