Quality Assurance Specialist II - 2nd Shift

Job description

Quality Assurance Specialist II Location: This is an on-site position located in Pearland, TX. Available shift: Second shift, Tuesday through Saturday, 3:00 pm to 12:00 am. The Quality Assurance Specialist II represents the QA department to ensure quality and compliance requirements are met in support of manufacturing operations. This role provides QA oversight on the production floor, supports batch disposition activities, and collaborates with cross-functional teams to maintain cGMP compliance. The position also supports investigations, deviations, and change controls while ensuring timely and accurate review of GMP documentation in a fast-paced manufacturing environment. What you will get: This is a competitive, salary position. In addition, below you will find a comprehensive summary of the benefits package we offer: • Performance-related bonus (~7.5%) and shift differential. • 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: • Review and approve GMP documentation including batch records, QC testing records, and supporting documents for batch disposition. • Provide QA oversight on the manufacturing floor, including walkthroughs, line clearances, and critical unit operations support. • Perform QA walkthroughs and work closely with manufacturing and support groups to resolve quality issues. • Ensure compliance with cGMP, ISO standards, and internal quality systems. • Support deviations, CAPAs, change controls, and investigations using problem-solving tools. • Maintain and track quality records to ensure audit readiness and timely completion. • Support QA on-the-floor activities including Level 3 gowning (Grade B) for critical operations. • Collaborate cross-functionally with Manufacturing, QC, Facilities, and Engineering teams. What we are looking for: • 0–4 years of experience in Quality Assurance, Quality Control, or GMP-regulated manufacturing environment. • Minimum of a Bachelor’s degree in a scientific discipline (Life Sciences or Engineering preferred). • Working knowledge of cGMP, GDP, and regulatory standards. • Experience reviewing batch records, QC documentation, and supporting manufacturing processes preferred. • Familiarity with deviations, investigations, CAPA, and quality systems preferred. • Strong communication and collaboration skills across cross-functional teams. • Comfortable working in cleanroom environments and performing Level 3 gowning. • Proficiency with documentation systems and standard office software. 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.