QA Analyst

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

Benefits offered by this job

Medical, dental, and vision coverage

401(k) and matching

PTO and holidays

Education assistance

Pet Insurance

Fitness perks

Employee discounts

Job summary

BioTechnique is seeking a QA Analyst to support quality assurance activities within a GMP-regulated sterile manufacturing environment. The role emphasizes routine QA oversight, documentation reviews, and cross-functional collaboration to maintain inspection readiness and product quality.

The candidate will review batch records, support deviations and CAPAs, and assist with risk assessments and validation activities to ensure compliance with quality requirements.

Qualifications

• Bachelor's degree in Life Sciences or related technical discipline required
• 2+ years of GMP-regulated pharmaceutical/biopharmaceutical manufacturing experience
• Experience with deviations, investigations, CAPAs, change controls, and quality risk management
• Knowledge of GMP documentation review and batch records
• Experience with sterile/aseptic manufacturing operations, environmental monitoring, APS/media fills, sterilization, and contamination control
• Strong detail orientation and cross-functional collaboration skills

Responsibilities

• Review batch records, logbooks, and GMP documentation for accuracy and compliance
• Provide QA oversight of sterile manufacturing and related operations
• Support deviations, investigations, CAPAs, and change controls
• Assist with risk assessments, impact analyses, and regulatory inspections readiness
• Review and approve GMP documentation within assigned authority
• Provide QA support for aseptic processing and contamination-control activities
• Support environmental monitoring and sterilization activities
• Collaborate with Manufacturing, QC, Engineering, Validation, and Warehouse to address quality needs

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 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 escalation 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

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.

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