Quality Control Analyst I

Lonza; Walkersville (MD); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Job summary

Lonza in Walkersville, MD is seeking a Quality Control Analyst I to perform routine and moderately complex laboratory testing in support of GMP manufacturing and stability programs. This role blends hands-on execution with data analysis, investigations, and documentation to ensure compliant results.

The position is on-site, Monday–Friday, 8:00 AM–5:00 PM EST. Candidates should have an associate degree or equivalent and at least 2 years in a regulated lab, with experience in GMP stability,

Qualifications

• Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience preferred; GMP lab experience may count in lieu of degree.
• Minimum of 2 years of experience in a pharmaceutical/biotech or regulated lab setting.
• Experience supporting GMP stability programs, sample management, and documentation.

Responsibilities

• Perform routine and moderately complex lab testing of in-process, release, environmental monitoring, and stability samples.
• Conduct environmental monitoring in cleanroom environments using viable and non-viable methods.
• Review and interpret data to ensure accurate, timely reporting of results.
• Support GMP stability programs including protocol execution and inventory management.
• Participate in investigations (OOS/OOT/ environmental excursions) and assist with CAPAs and root-cause analysis.
• Author and maintain GMP documentation (SOPs, methods, protocols, reports).
• Train staff on analytical techniques and environmental monitoring practices.
• Support day-to-day lab operations and external coordination.

Skills

Lab testing

Data analysis

Documentation

Analytical thinking

Cross-team collaboration

Education

Associate degree or equivalent

Tools

GMP environment

Job description

Quality Control Analyst I

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 $61,200 to $71,400. 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 will you do:

We are seeking a Quality Control Analyst I 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 monitoring, and stability samples with minimal supervision

• Conduct environmental monitoring activities within classified cleanroom environments, including viable and non‑viable monitoring, surface sampling, personnel monitoring, and utility monitoring as applicable

• 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), out‑of-trend (OOT), environmental monitoring excursions, 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, environmental monitoring practices, procedures, and best practices

• Support day‑to‑day laboratory operations, including sample management, inventory control, equipment maintenance, cleanroom monitoring activities, 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 2 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

• Experience performing environmental monitoring activities in GMP cleanroom environments, including viable and non‑viable air monitoring, surface sampling, and personnel monitoring preferred

• Working knowledge of analytical laboratory techniques, aseptic practices, cleanroom behavior, contamination control principles, and GMP laboratory operations

• Familiarity with GMP regulations, data integrity principles, quality systems, and laboratory compliance requirements

• Experience supporting laboratory investigations, including deviations, OOS, OOT results, CAPAs, environmental monitoring excursions, or other quality events

• Strong analytical, organizational, troubleshooting, and problem‑solving skills, with the ability to effectively manage multiple priorities and maintain accurate laboratory documentation

• Strong written and verbal communication skills, with the ability to work collaboratively across teams in a GMP manufacturing environment

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?