Senior QA Specialist - Sterile Manufacturing (cGMP)

PSC Biotech® Corporation; York (York County); Sur place; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental & Vision

401(k) matching

PTO & holidays

Education assistance

Pet insurance

Fitness perks

Résumé du poste

BioTechnique is seeking a Senior QA Specialist to provide QA oversight for sterile and aseptic manufacturing, ensuring compliance with cGMP and established quality standards. The role reviews GMP documentation, investigations, CAPAs, and validation records while partnering with Manufacturing, Quality Control, Engineering and Validation to drive continuous improvement.

The ideal candidate has a Life Sciences or related degree and 6+ years of QA experience in a cGMP environment, with hands-on

Qualifications

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

Responsabilités

• Provide QA oversight of sterile and aseptic manufacturing operations to ensure compliance with cGMP requirements, procedures, and quality standards.
• Review and approve batch records and GMP documentation supporting product quality and disposition.
• Lead and review deviations, investigations, CAPAs, and effectiveness checks.
• Review and approve change controls, risk assessments, and qualification/validation documentation.
• Provide QA oversight for aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control.

Connaissances

QA oversight

cGMP

Documentation

Cross-functional collaboration

Audits

Problem-solving

Communication

Formation

Bachelor’s degree in Life Sciences/Engineering/Quality

Description du poste

BioTechnique is seeking a Senior QA Specialist to provide QA oversight for sterile and aseptic manufacturing, ensuring compliance with cGMP and established quality standards. The role reviews GMP documentation, investigations, CAPAs, and validation records while partnering with Manufacturing, Quality Control, Engineering and Validation to drive continuous improvement.

The ideal candidate has a Life Sciences or related degree and 6+ years of QA experience in a cGMP environment, with hands-on