Senior QA Leader - Sterile Fill-Finish

PSC Biotech; Nebraska; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, and Vision - PSC pays

Insurance options for EAP, Life, STD/L

401(k) and 401(k) matching

PTO, Sick Time, and Paid Holidays

Education Assistance

Pet Insurance

Fitness Perks and Discounted Rates

Financial Perks and Discounts

Job summary

PSC Biotech is seeking a Senior QA Specialist to provide QA oversight of sterile and aseptic manufacturing operations, ensuring cGMP compliance and GMP documentation control. You will review batch records, lead investigations, and support change controls and risk assessments across cross-functional teams.

You will collaborate closely with Manufacturing, Quality Control, Engineering and Validation, driving continuous improvement and inspection readiness.

Qualifications

• 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 elevate 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 quality, compliance, and patient safety risks.
• Provide 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.

Skills

QA oversight

cGMP knowledge

Documentation

Problem-solving

Education

Bachelor's degree

Life Sciences

Engineering

Quality

Job description

PSC Biotech is seeking a Senior QA Specialist to provide QA oversight of sterile and aseptic manufacturing operations, ensuring cGMP compliance and GMP documentation control. You will review batch records, lead investigations, and support change controls and risk assessments across cross-functional teams.

You will collaborate closely with Manufacturing, Quality Control, Engineering and Validation, driving continuous improvement and inspection readiness.