GMP QA Analyst: Sterile Manufacturing & Compliance

PSC Biotech; Nebraska; Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical premiums paid

Dental premiums paid

Vision premiums paid

401(k) matching

PTO and holidays

Education assistance

Pet Insurance

Fitness perks

Discounts

Résumé du poste

PSC Biotech is seeking a QA Analyst to support QA in a GMP-regulated sterile manufacturing environment, focusing on documentation compliance and quality oversight. You will review records, support deviations and CAPAs, and help ensure manufacturing activities meet quality requirements.

You will collaborate with Manufacturing, QC, Engineering, Validation, and other teams to maintain inspection readiness and promote product quality across the facility.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 2+ years in GMP-regulated pharma/biotech manufacturing.
• Knowledge of GMP documentation and deviations/CAPAs.
• Experience with sterile manufacturing operations.

Responsabilités

• Review batch records, logbooks, and GMP documentation for accuracy, completeness, and compliance.
• Provide routine QA oversight of sterile manufacturing and supporting operations.
• Initiate and support deviations, investigations, 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, APS/media fills, and sterilization activities.
• Support qualification and validation activities to ensure compliance with applicable quality requirements.
• Identify, document, and escalation 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.

Connaissances

GMP knowledge

Quality systems

Attention to detail

Formation

Bachelor's degree in Life Sciences

Description du poste

PSC Biotech is seeking a QA Analyst to support QA in a GMP-regulated sterile manufacturing environment, focusing on documentation compliance and quality oversight. You will review records, support deviations and CAPAs, and help ensure manufacturing activities meet quality requirements.

You will collaborate with Manufacturing, QC, Engineering, Validation, and other teams to maintain inspection readiness and promote product quality across the facility.