QA Specialist I

PSC Biotech; York (York County); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) with matching

Paid time off and holidays

Education assistance

Job summary

BioTechnique is a sterile injectable CDMO providing fill-finish and related services. The QA Specialist I ensures routine quality oversight across manufacturing operations and supports compliant execution with timely quality reviews.

The role requires a life sciences degree and GMP experience, with strong attention to detail and ability to collaborate across Quality, Manufacturing, and Validation teams.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or related technical discipline.
• 2+ years experience in a GMP-regulated pharmaceutical/biotech manufacturing environment.
• Knowledge of GMP requirements and quality systems within a regulated setting.
• Familiarity with deviations, investigations, CAPAs, change controls, and quality risk management.
• Understanding of batch record and GMP documentation review practices.

Responsibilities

• Perform floor walkthroughs, review manufacturing documentation, and verify GMP compliance.
• Support line clearance, material-status confirmation, visual inspection, and AQL activities.
• Identify documentation or operational discrepancies and support deviations, investigations, and batch record reviews.

Skills

GMP knowledge

Quality systems

Documentation

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Life Sciences or related

Tools

QMS software

Job description

Job Description

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.

The Experience

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.

Your Role

The QA Specialist I provides routine Quality oversight and support to manufacturing, packaging, inspection, material handling, and related GMP operations. The role supports compliant execution and documentation of manufacturing activities through direct floor presence and timely Quality review.

• Perform floor walkthroughs, review manufacturing documentation, and verify compliance with applicable GMP practices.
• Support line clearance, component and material-status confirmation, visual inspection, and AQL activities.
• Identify documentation or operational discrepancies and support deviation initiation, investigations, batch record review, environmental monitoring, sampling, and product-inspection activities.
• Promote Good Documentation Practices and provide immediate Quality guidance when routine GMP issues are identified.
• Escalate significant or recurring issues to senior Quality personnel.

Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or a related technical discipline.
• 2+ years Experience working in a GMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or related manufacturing environment.
• Knowledge of GMP requirements and quality systems within a regulated manufacturing setting.
• Familiarity with deviations, investigations, CAPAs, change controls, and quality risk management.
• Understanding of batch record and GMP documentation review practices.
• Familiarity with sterile or aseptic manufacturing operations, environmental monitoring, APS/media fills, sterilization, and contamination control.
• Ability to identify and appropriately quality and compliance concerns.
• Strong attention to detail, organizational skills, and written and verbal communication skills.
• Ability to collaborate effectively across Quality, Manufacturing, Engineering, Validation, QC, Warehouse, and other functional groups.

Benefits

Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• 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

Equal Opportunity Employment Statement

BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs,including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.