Quality Control Analyst II
Lonza
Summary
We are seeking a Quality Control Analyst II to perform routine and moderately complex laboratory testing in support of GMP manufacturing and stability programs. This role combines hands-on laboratory execution with data analysis, troubleshooting, investigations, and documentation activities. The successful candidate will contribute to laboratory operations while maintaining compliance with regulatory requirements and supporting continuous improvement initiatives.
Job description
What will you do:
- Perform routine and moderately complex testing of in-process, release, environmental, and stability samples with minimal supervision
- Review, analyze, and interpret laboratory data to ensure accurate, complete, and timely reporting of results
- Support GMP stability programs, including stability protocol execution, sample inventory management, testing coordination, and documentation review
- Participate in laboratory investigations, including deviations, out-of-specification (OOS), and atypical results, identifying root causes and supporting corrective actions
- Author, revise, and maintain SOPs, test methods, protocols, reports, and other GMP documentation
- Train and support laboratory personnel on analytical techniques, procedures, and best practices
- Assist with method transfers, validation activities, equipment qualification efforts, and continuous improvement projects
- Support day-to-day laboratory operations, including sample management, inventory control, equipment maintenance, and external laboratory coordination
What we are looking for:
- Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience preferred; relevant GMP laboratory experience may be considered in lieu of formal education
- Minimum of 3 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment
- Experience supporting GMP stability programs, including sample management, testing coordination, inventory tracking, and documentation activities preferred
- Working knowledge of analytical laboratory techniques, aseptic practices, and GMP laboratory operations
- Familiarity with GMP regulations, data integrity principles, quality systems, and laboratory compliance requirements Experience supporting laboratory investigations, including deviations, out-of-specification (OOS) results, CAPAs, or other quality events
- Strong analytical, organizational, troubleshooting, and problem-solving skills, with the ability to effectively manage multiple priorities
- Strong written and verbal communication skills, with the ability to work collaboratively across teams and maintain accurate laboratory documentation
Requirements
- Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience preferred
- Minimum of 3 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment
- Experience supporting GMP stability programs, including sample management, testing coordination, inventory tracking, and documentation activities preferred
- Working knowledge of analytical laboratory techniques, aseptic practices, and GMP laboratory operations
- Familiarity with GMP regulations, data integrity principles, quality systems, and laboratory compliance requirements
- Experience supporting laboratory investigations, including deviations, out-of-specification (OOS) results, CAPAs, or other quality events
- Strong analytical, organizational, troubleshooting, and problem-solving skills
- Strong written and verbal communication skills
Benefits
- Performance-related bonus
- Medical, Dental & Vision
- 401(k) Matching
- Life Insurance
- Short-term Disability
- Long-term Disability
- Employee Assistance Programs
- Paid Time Off
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.