Quality Control Analyst II

Lonza Inc. in; Walkersville (MD); On-site; USD 70,000 - 82,000; Full time

Benefits offered by this job

Bonus

Medical Insurance

Dental Insurance

Vision Insurance

401(k) matching

Life Insurance

Disability Insurance

Employee Assistance

Paid Time Off

Job summary

Lonza Inc. is seeking a Quality Control Analyst II to join our Walkersville, MD team. The role combines hands-on laboratory testing with data analysis, investigations, and documentation to support GMP manufacturing and stability programs.

You will perform routine and moderately complex testing, review data for timely reporting, and help maintain SOPs and GMP documentation. A strong communication skillset and collaboration across teams are essential.

Qualifications

• Associate degree, technical certification, or equivalent in a laboratory field.
• Minimum 3 years of experience in a pharmaceutical/biotech or regulated lab.
• Experience supporting GMP stability programs and data integrity knowledge.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Perform routine and moderately complex testing of in-process, release, environmental, and stability samples.
• Review and interpret laboratory data for accurate, timely reporting of results.
• Support GMP stability protocols, sample management, testing coordination and documentation review.
• Participate in investigations for deviations and OOS with root-cause analyses.
• Author and maintain SOPs, test methods, and GMP documentation.
• Train staff on analytical methods and best practices.
• Assist with method transfers, validation, and equipment qualification.
• Maintain day-to-day lab operations including inventory and coordination with external labs.

Job description

Location: This position is based in our Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What you will get:

The full-time base annual salary for this position is expected to range between $70,200 to $81,900.

• 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 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.

• 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

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.