QA Specialist

Job Title:

QA Analyst

Bio Technique 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. Bio Technique 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, Bio Technique 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 Bio Technique, 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.

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 escalate 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 Bio Technique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

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