QA Operations Specialist III - LSA

Requirements

• Bachelor's degree in life sciences discipline or equivalent experience
• 5-8 years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment
• Strong understanding of cGMP, ICH guidelines, and quality systems
• Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions
• Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications
• Ability to independently assess quality issues, make sound decisions, and appropriately escalate complex situations
• Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor
• Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

QA Operations Specialist III - LSA Location: This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM - 7:00 AM). The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays, and continues a biweekly rotation. What you will get: 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 will you do: We are seeking an experienced QA Operations Specialist III to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational areas, ensuring compliance, supporting decision-making, and driving high standards of GMP execution. The ideal candidate brings strong technical expertise, sound judgment, and the ability to operate independently while mentoring others. Provide real-time QA support within GMP manufacturing areas, including on-the-floor presence, observation of operations, and review of GMP work practices Perform real-time review of batch records (paper and electronic), logbooks, and other GMP documentation to ensure accuracy and compliance Respond to QA hotline calls, assess quality issues, and make independent, risk-based decisions, escalating as appropriate Provide guidance to manufacturing routine and non-routine quality issues, including coaching on GMP requirements and documentation practices Authorize and manage Quality Tag Out activities, including placement and removal in accordance with procedures Identify, assess, and support resolution of deviations and non-conformances, ensuring appropriate escalation and follow-up Serve as a resource and mentor to junior QA staff, providing coaching, training, and support in GMP decision-making Participate in cross-functional meetings and initiatives, representing QA and contributing to continuous improvement and inspection readiness

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