Quality Control Analyst I

Lonza•Walkersville, MD

19h•$61,200 - $71,400•Onsite

About The Position

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.

Requirements

Minimum of 2 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment
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
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

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

Responsibilities

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