Quality Control Analyst II

Lonza•Walkersville, MD

8d•$70,200 - $81,900•Onsite

About The Position

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.

Requirements

Minimum of 3 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment
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

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

Responsibilities

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