Quality Control Analyst I

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

Benefits offered by this job

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza Walkersville, MD is seeking a Quality Control Analyst I to perform routine sampling and testing in support of GMP manufacturing. You will conduct environmental monitoring, testing of materials, in-process and finished products, and stability samples with a focus on data integrity and compliant documentation.

The ideal candidate holds an associate degree or technical certification and has at least two years in a regulated lab environment.

Qualifications

• Associate degree or technical certification preferred; relevant GMP lab experience may be considered in lieu of formal education.
• Minimum 2 years of pharmaceutical, biotech, life sciences, or other regulated lab experience.

Responsibilities

• Perform routine sampling and testing of environmental monitoring, utilities, raw materials, in-process materials, finished products, and stability samples per SOPs and cGMP.
• Execute laboratory testing and support activities within established timelines, maintaining accuracy and compliance.
• Document, review, and report laboratory data following GDP and ALCOA+ principles.

Skills

Environmental monitoring

cGMP

GDP/ALCOA+ data integrity

Documentation accuracy

Time management

Education

Associate degree

Technical certification

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 $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 laboratory sampling and testing activities in support of GMP manufacturing operations. This role is primarily focused on the execution of environmental monitoring, utility, raw material, in-process, finished product, and stability testing while ensuring compliance with cGMP requirements, data integrity standards, and approved procedures. The successful candidate will contribute to laboratory operations through accurate testing, documentation, and sample management activities.

Perform routine sampling and testing of environmental monitoring (EM), utilities, raw materials, in-process materials, finished products, and stability samples in accordance with approved procedures and cGMP requirements.

Execute assigned laboratory testing and support activities within established timelines while maintaining accuracy, quality, and compliance.

Accurately document, review, and report laboratory data in compliance with Good Documentation Practices (GDP) and ALCOA+ data integrity principles.

Conduct environmental monitoring activities within classified manufacturing and laboratory environments, including viable and non-viable monitoring, surface sampling, and personnel monitoring as applicable.

Support sample receipt, handling, storage, inventory tracking, and shipment coordination with external testing laboratories.

Support day-to-day laboratory operations, including housekeeping, inventory management, material stocking, and routine equipment care.

Identify, document, and lift deviations, atypical results, out-of-specification (OOS) results, or compliance concerns in accordance with quality procedures.

Participate in training activities to expand technical proficiency and support validation, continuous improvement, or innovation projects as assigned.

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 performing routine laboratory testing and sample handling activities in a GMP-regulated environment.

Experience performing environmental monitoring activities, including viable and non-viable air sampling, surface sampling, personnel monitoring, or utility sampling preferred.

Working knowledge of aseptic technique, contamination control principles, laboratory practices, and cGMP requirements.

Understanding of Good Documentation Practices (GDP), ALCOA+ principles, and data integrity requirements.

Ability to accurately follow written procedures, maintain laboratory records, and execute testing with attention to detail.

Strong organizational and time-management skills with the ability to manage multiple testing priorities under supervision.

Effective written and verbal communication skills and the ability to work collaboratively within a quality and 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.