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.
What you will do
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.
What we are looking for
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).
Familiarity with root cause analysis tools, risk management, technical writing, and systems such as TrackWise, DMS, SAP, Microsoft Office, and LIMS (preferred).
Ability to prioritize effectively in a fast‑paced environment with multiple competing deadlines.
Commitment to following all company and site safety policies.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.