QA Analyst

PSC Biotech•York, PA

1d•Onsite

About The Position

The QA Analyst supports Quality Assurance activities within a GMP-regulated manufacturing environment, with a focus on sterile manufacturing operations and documentation compliance. This role provides routine QA oversight, reviews and approves GMP documentation, supports quality investigations and risk assessments, and helps ensure manufacturing activities meet established quality and compliance requirements. The QA Analyst works cross-functionally with Manufacturing, Quality Control, Engineering, Validation, Warehouse, and other teams to maintain inspection readiness and promote product quality.

Requirements

Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or a related technical discipline.
2+ years Experience working in a GMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or related manufacturing environment.
Knowledge of GMP requirements and quality systems within a regulated manufacturing setting.
Familiarity with deviations, investigations, CAPAs, change controls, and quality risk management.
Understanding of batch record and GMP documentation review practices.
Familiarity with sterile or aseptic manufacturing operations, environmental monitoring, APS/media fills, sterilization, and contamination control.
Ability to identify and appropriately escalate quality and compliance concerns.
Strong attention to detail, organizational skills, and written and verbal communication skills.
Ability to collaborate effectively across Quality, Manufacturing, Engineering, Validation, QC, Warehouse, and other functional groups.

Responsibilities

Review batch records, logbooks, and other GMP documentation for accuracy, completeness, and compliance.
Provide routine Quality Assurance oversight of sterile manufacturing and supporting operations.
Initiate and support deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls.
Support root cause analyses, impact assessments, and quality risk assessments.
Review and approve GMP documentation within assigned level of authority.
Provide QA support for aseptic processing and contamination-control activities.
Support environmental monitoring, aseptic process simulations (APS)/media fills, and sterilization activities.
Support qualification and validation activities to ensure compliance with applicable quality requirements.
Identify, document, and escalate potential GMP, product quality, and compliance concerns.
Support internal audits, customer audits, and regulatory inspection readiness activities.
Collaborate cross-functionally with Manufacturing, QC, Engineering, Validation, Warehouse, and other departments to address quality and compliance needs.