Senior QA Specialist (Sterile Manufacturing)

Location: York, United States

Company

hirify.global's BioTechnique division provides sterile injectable fill-finish and lyophilization services for pharmaceutical and biopharmaceutical products, from IND applications through commercial-scale production.

What you will do

• Provide Quality Assurance oversight for sterile and aseptic manufacturing operations in compliance with cGMP requirements and approved procedures.
• Review and approve batch records and other GMP documentation supporting product quality and disposition.
• Lead and review deviations, investigations, root cause analyses, CAPAs, effectiveness checks, and change controls.
• Review quality risk assessments and qualification and validation documentation.
• Oversee aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control activities.
• Support regulatory and customer audits, inspection readiness, risk escalation, and continuous improvement initiatives.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical discipline.
• 6+ years of Quality Assurance experience in pharmaceutical, biopharmaceutical, or other cGMP-regulated manufacturing.
• Experience supporting sterile and/or aseptic manufacturing operations.
• Strong knowledge of cGMP requirements, quality systems, GMP documentation, deviations, investigations, CAPAs, change controls, and risk assessments.
• Experience with batch record review and qualification or validation documentation.
• Ability to identify and escalate quality, compliance, and patient safety risks and collaborate across Manufacturing, Quality Control, Engineering, and Validation.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance, basic life insurance, short- and long-term disability, and other insurance options.
• 401(k) plan with matching.
• PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.