Quality Control Analyst II

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

Benefits offered by this job

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term disability

Long-term disability

Employee assistance programs

Paid time off

Performance-related bonus

Job summary

Lonza in Walkersville, MD seeks a Quality Control Analyst II 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 while ensuring regulatory compliance.

The ideal candidate will review data, support stability protocol execution, manage samples, and participate in investigations.

Qualifications

• Associate degree or equivalent with GMP lab experience preferred
• Minimum 3 years in a pharmaceutical, biotech, life sciences, or other regulated lab environment
• Experience supporting GMP stability programs, sample management, testing coordination, and documentation
• Knowledge of analytical laboratory techniques, aseptic practices, and GMP laboratory operations
• Strong written and verbal communication; ability to multitask across priorities

Responsibilities

• Perform routine and moderately complex testing of in-process, release, environmental, and stability samples
• Review, analyze, and interpret data to ensure accurate reporting of results
• Support GMP stability programs, including protocol execution, sample inventory management, testing coordination, and documentation review
• Participate in laboratory investigations, deviations, OOS, and atypical results, identifying root causes
• Author, revise, and maintain SOPs, test methods, protocols, reports, and GMP documentation
• Train and support laboratory personnel on analytical techniques, procedures, and best practices
• Assist with method transfers, validation activities, equipment qualification, and continuous improvement projects
• Support day-to-day laboratory operations, including sample management and inventory control

Skills

Analytical skills

Troubleshooting

Problem-solving

Organization

Communication

Education

Associate degree

Tools

Laboratory equipment

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. 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 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.

Reference: R77619

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.