Senior QA Specialist

PSC Biotech • York, PA

3d

About The Position

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At BioTechnique, it’s about more than just a job—it’s about your career and your future.

Requirements

• 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 escalate 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 risks related to product quality, patient safety, and regulatory compliance.
• Provide appropriate 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.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior