Senior Quality Assurance Specialist

Job overview

The Senior Quality Assurance Specialist role is onsite in York, PA. Compensation is $85,000–$103,000 per year. BioTechnique provides sterile injectable fill-finish services, and this role supports quality oversight of sterile and aseptic manufacturing operations.

What you'll do

• Provide QA oversight to ensure cGMP and procedure compliance
• review and approve batch records and GMP documentation
• lead or review deviations, investigations, root-cause analyses, CAPAs, and effectiveness checks
• review change controls, risk assessments, and qualification and validation documentation
• oversee aseptic processing, media fills, environmental monitoring, sterilization, and contamination control
• identify and escalate quality, compliance, and patient-safety risks
• support audits, inspection readiness, and continuous improvement
• collaborate with Manufacturing, Quality Control, Engineering, and Validation.

What we're looking for

Skills & competencies

senior quality assurance specialist

quality assurance

cgmp

sterile manufacturing

aseptic processing

capa

batch records

york pa

psc biotech

$85k–$103k/year

regulatory audits

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage
• employee assistance program
• basic life and disability insurance
• 401(k) and matching
• paid time off, sick time, and paid holidays
• education assistance
• pet insurance
• fitness and financial perks.

Why this role

The posting requires six or more years of Quality Assurance experience in a pharmaceutical, biopharmaceutical, or other cGMP-regulated manufacturing environment, including sterile or aseptic operations.

About the employer

PSC Biotech is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.