Senior QA Specialist

PSC Biotech•York, PA

About The Position

The Senior QA Specialist provides Quality Assurance oversight and guidance for sterile and aseptic manufacturing operations, ensuring compliance with cGMP requirements, approved procedures, and established quality standards. This role supports product quality and disposition activities through the review and approval of GMP documentation, investigations, CAPAs, change controls, risk assessments, and qualification/validation documentation. The Senior QA Specialist partners cross-functionally with Manufacturing, Quality Control, Engineering, Validation, and other teams to identify and mitigate quality and compliance risks while supporting inspection readiness and continuous improvement.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Quality, or a related technical discipline.
6+ years experience in Quality Assurance within a pharmaceutical, biopharmaceutical, or other cGMP-regulated manufacturing environment.
Experience supporting sterile and/or aseptic manufacturing operations.
Strong knowledge of cGMP requirements and quality systems.
Experience reviewing batch records and other GMP-controlled documentation.
Experience with deviations, investigations, root cause analysis, CAPAs, change controls, and quality risk assessments.
Familiarity with aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control principles.
Experience reviewing qualification and/or validation documentation.
Ability to identify and escalate quality, compliance, and patient safety risks.
Strong communication, documentation, problem-solving, and cross-functional collaboration skills.
Ability to support regulatory and customer audits and inspection readiness activities.

Responsibilities

Provide QA oversight of sterile and aseptic manufacturing operations to ensure compliance with cGMP requirements, approved procedures, and quality standards.
Review and approve batch records and GMP documentation in support of product quality and disposition activities.
Lead and review deviations, investigations, root cause analyses, CAPAs, and effectiveness checks.
Review and approve change controls, quality risk assessments, and qualification and validation documentation.
Provide QA oversight for aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control activities.
Identify, assess, and escalate risks related to product quality, patient safety, and regulatory compliance.
Provide appropriate GMP and quality guidance to cross-functional teams.
Support customer and regulatory audits, inspection readiness activities, and continuous improvement initiatives.
Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other functions to address quality and compliance needs.