QA Analyst

PSC Biotech® Corporation; York (York County); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

401(k) with match

Paid Time Off

Education Assistance

Pet Insurance

Fitness Perks

Discounts

Job summary

BioTechnique is seeking a QA Analyst to provide QA oversight within a GMP-regulated sterile manufacturing environment. The role emphasizes reviewing documentation, ensuring inspection readiness, and supporting CAPAs, deviations, and regulatory compliance.

The position collaborates with Manufacturing, QC, Engineering, Validation, and Warehouse teams to maintain product quality and compliance across operations.

Qualifications

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

Responsibilities

• Review batch records, logbooks, and GMP docs for accuracy and compliance.
• Provide QA oversight of sterile manufacturing and related operations.
• Support deviations, investigations, CAPAs, and change controls.
• Assist root cause analyses and risk assessments.
• Review GMP documentation within assigned authority levels.
• Provide QA support for aseptic processing and contamination-control activities.
• Support environmental monitoring, APS/media fills, and sterilization.
• Assist qualification and validation activities ensuring compliance.
• Identify and elevate GMP and quality concerns.
• Support internal and customer audits and regulatory readiness.

Skills

GMP knowledge

Quality systems

Documentation review

Aseptic manufacturing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

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-its about your career and your future.

Your Role

The QA Analyst supports Quality Assurance activities within a GMP-regulated manufacturing environment, with a focus on sterile manufacturing operations and documentation compliance. This role provides routine QA oversight, reviews and approves GMP documentation, supports quality investigations and risk assessments, and helps ensure manufacturing activities meet established quality and compliance requirements. The QA Analyst works cross-functionally with Manufacturing, Quality Control, Engineering, Validation, Warehouse, and other teams to maintain inspection readiness and promote product quality.

• Review batch records, logbooks, and other GMP documentation for accuracy, completeness, and compliance.
  
• Provide routine Quality Assurance oversight of sterile manufacturing and supporting operations.
  
• Initiate and support deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls.
  
• Support root cause analyses, impact assessments, and quality risk assessments.
  
• Review and approve GMP documentation within assigned level of authority.
  
• Provide QA support for aseptic processing and contamination-control activities.
  
• Support environmental monitoring, aseptic process simulations (APS)/media fills, and sterilization activities.
  
• Support qualification and validation activities to ensure compliance with applicable quality requirements.
  
• Identify, document, and elevate potential GMP, product quality, and compliance concerns.
  
• Support internal audits, customer audits, and regulatory inspection readiness activities.
  
• Collaborate cross-functionally with Manufacturing, QC, Engineering, Validation, Warehouse, and other departments to address quality and compliance needs.
  

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 elevate 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

• 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.