Batch Release Specialist, Quality Assurance
About The Position
Batch Release Specialist – Quality Assurance (QA) Location: Houston, TX — On‑site Be part of a team that helps bring life‑changing therapies to patients around the world. At Lonza Houston, you’ll play a critical role in ensuring that products manufactured at our site meet the highest quality standards. This is an exciting opportunity to influence quality systems, support batch release, and contribute to continuous improvement across a fast‑growing biologics operation. What you will get A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
Requirements
- Bachelor’s degree in a Life Sciences field or equivalent relevant experience.
- Experience working in a cGMP environment, with commercial GMP exposure preferred; demonstrated expertise in batch disposition required.
- Strong working knowledge of GMP regulations (e.g., 21 CFR 210/211/820, EU GMP, PIC/S guidance, Annex 1, FDA aseptic processing guidance, Part 11 compliance).
- Ability to prioritize effectively in a fast‑paced environment with multiple competing deadlines.
- Commitment to following all company and site safety policies.
Nice To Haves
- Familiarity with root cause analysis tools, risk management, technical writing, and systems such as TrackWise, DMS, SAP, Microsoft Office, and LIMS (preferred).
Responsibilities
- Lead the disposition of all Cell Therapy batches manufactured at the LHI site, managing tracking systems and partnering cross‑functionally to ensure all required deliverables (e.g., batch records, deviations, change controls, EM reports) are completed.
- Mentor and coach junior team members in document review practices and implementation of Quality Systems.
- Collaborate closely with the Inspection Management team to identify and address compliance gaps across Quality Systems.
- Drive improvements by recommending and implementing changes that enhance compliance, effectiveness, and efficiency.
- Serve as a key QA representative during internal and external audits, ensuring site readiness and alignment with regulatory expectations.
- Support investigations, deviations, CAPAs, and change controls as owner or QA approver using effective problem‑solving methodologies.
- Promote cGMP compliance by ensuring all team activities follow established procedures, processes, and instructions.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- 401(k) matching plan.
- Life insurance, as well as short-term and long-term disability insurance.
- Employee assistance programs.
- Paid time off (PTO).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
