Quality Control Analyst I

Location: Walkersville, MD office

Pay

The full-time base annual salary for this position is expected to range between $61,200 to $71,400. Compensation will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Benefits

• 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)

Schedule

Monday through Friday, 8:00 AM–5:00 PM EST

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

Requirements

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

About the Company

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.