Quality Control Analyst I

Lonza•Walkersville, MD

3d•$61,200 - $71,400•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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

Responsibilities

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 escalate 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.