Senior QA Specialist - Sterile & cGMP Compliance

PSC Biotech; York (York County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) matching

PTO and holidays

Education assistance

Life insurance

Wellness programs

Job summary

BioTechnique seeks a Senior QA Specialist to oversee sterile and aseptic manufacturing quality, ensuring cGMP compliance and adherence to approved procedures. You will review GMP documentation, CAPAs, and change controls while partnering with Manufacturing, QC, Engineering, and Validation to mitigate risks.

The role requires a Bachelor's in Life Sciences/Engineering/Quality and 6+ years in pharma QA, with strong communication and auditing skills to support inspections and continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality or related technical discipline.
• 6+ years of QA experience in pharma, biopharma, or other cGMP-regulated manufacturing.
• Experience supporting sterile and/or aseptic manufacturing operations.
• Strong knowledge of cGMP requirements and quality systems.
• Experience reviewing batch records and GMP-controlled documentation.
• Experience with deviations, investigations, CAPAs, change controls, and quality risk assessments.
• Familiarity with aseptic processing, environmental monitoring, sterilization, and contamination control.

Responsibilities

• Provide QA oversight of sterile and aseptic manufacturing operations to ensure compliance with cGMP 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 risks related to product quality, patient safety, and regulatory compliance.
• Provide GMP and quality guidance to cross-functional teams.
• Support customer and regulatory audits, inspection readiness activities, and continuous improvement initiatives.

Skills

Communication

Documentation

Problem-solving

Cross-functional collaboration

Regulatory knowledge

Auditing

Education

Bachelor's degree in Life Sciences/Engineering/Quality

Job description

BioTechnique seeks a Senior QA Specialist to oversee sterile and aseptic manufacturing quality, ensuring cGMP compliance and adherence to approved procedures. You will review GMP documentation, CAPAs, and change controls while partnering with Manufacturing, QC, Engineering, and Validation to mitigate risks.

The role requires a Bachelor's in Life Sciences/Engineering/Quality and 6+ years in pharma QA, with strong communication and auditing skills to support inspections and continuous improvement.