GMP QA Analyst – Sterile Fill-Finish

PSC Biotech; York (York County); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision coverage

401(k) and matching

PTO and holidays

Education assistance

Pet Insurance

Fitness perks

Employee discounts

Résumé du poste

BioTechnique is seeking a QA Analyst to support quality assurance activities within a GMP-regulated sterile manufacturing environment. The role emphasizes routine QA oversight, documentation reviews, and cross-functional collaboration to maintain inspection readiness and product quality.

The candidate will review batch records, support deviations and CAPAs, and assist with risk assessments and validation activities to ensure compliance with quality requirements.

Qualifications

• Bachelor's degree in Life Sciences or related technical discipline required
• 2+ years of GMP-regulated pharmaceutical/biopharmaceutical manufacturing experience
• Experience with deviations, investigations, CAPAs, change controls, and quality risk management
• Knowledge of GMP documentation review and batch records
• Experience with sterile/aseptic manufacturing operations, environmental monitoring, APS/media fills, sterilization, and contamination control
• Strong detail orientation and cross-functional collaboration skills

Responsabilités

• Review batch records, logbooks, and GMP documentation for accuracy and compliance
• Provide QA oversight of sterile manufacturing and related operations
• Support deviations, investigations, CAPAs, and change controls
• Assist with risk assessments, impact analyses, and regulatory inspections readiness
• Review and approve GMP documentation within assigned authority
• Provide QA support for aseptic processing and contamination-control activities
• Support environmental monitoring and sterilization activities
• Collaborate with Manufacturing, QC, Engineering, Validation, and Warehouse to address quality needs

Description du poste

BioTechnique is seeking a QA Analyst to support quality assurance activities within a GMP-regulated sterile manufacturing environment. The role emphasizes routine QA oversight, documentation reviews, and cross-functional collaboration to maintain inspection readiness and product quality.

The candidate will review batch records, support deviations and CAPAs, and assist with risk assessments and validation activities to ensure compliance with quality requirements.