GMP QA Analyst - Sterile Fill-Finish

PSC Biotech® Corporation; York (York County); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

401(k) with match

Paid Time Off

Education Assistance

Pet Insurance

Fitness Perks

Discounts

Job summary

BioTechnique is seeking a QA Analyst to provide QA oversight within a GMP-regulated sterile manufacturing environment. The role emphasizes reviewing documentation, ensuring inspection readiness, and supporting CAPAs, deviations, and regulatory compliance.

The position collaborates with Manufacturing, QC, Engineering, Validation, and Warehouse teams to maintain product quality and compliance across operations.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or related discipline.
• 2+ years experience in GMP-regulated pharma/biotech manufacturing.
• Knowledge of GMP requirements and quality systems in regulated settings.
• Familiarity with deviations, investigations, CAPAs, change controls, and risk management.
• Understanding of batch records and GMP documentation review.

Responsibilities

• Review batch records, logbooks, and GMP docs for accuracy and compliance.
• Provide QA oversight of sterile manufacturing and related operations.
• Support deviations, investigations, CAPAs, and change controls.
• Assist root cause analyses and risk assessments.
• Review GMP documentation within assigned authority levels.
• Provide QA support for aseptic processing and contamination-control activities.
• Support environmental monitoring, APS/media fills, and sterilization.
• Assist qualification and validation activities ensuring compliance.
• Identify and elevate GMP and quality concerns.
• Support internal and customer audits and regulatory readiness.

Skills

GMP knowledge

Quality systems

Documentation review

Aseptic manufacturing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

BioTechnique is seeking a QA Analyst to provide QA oversight within a GMP-regulated sterile manufacturing environment. The role emphasizes reviewing documentation, ensuring inspection readiness, and supporting CAPAs, deviations, and regulatory compliance.

The position collaborates with Manufacturing, QC, Engineering, Validation, and Warehouse teams to maintain product quality and compliance across operations.