Quality Control Analyst I
$61,200–$71,400 year
On-siteWalkersville, Maryland, United States
Job Summary
Conduct routine and moderately complex laboratory testing for in-process, release, environmental monitoring, and stability samples within GMP cleanroom environments. Analyze and interpret laboratory data to ensure accurate reporting while supporting stability protocols, sample inventory management, and equipment maintenance. Participate in investigations for deviations, out-of-specification results, and environmental excursions to identify root causes and support corrective actions. Author and maintain SOPs, test methods, and GMP documentation while training personnel on analytical techniques and aseptic practices. Perform viable and non-viable air monitoring, surface sampling, and personnel monitoring as applicable.
Required Qualifications
- Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience
- 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
- Experience performing environmental monitoring activities in GMP cleanroom environments, including viable and non-viable air monitoring, surface sampling, and personnel monitoring
- 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
Desired Qualifications
- Relevant GMP laboratory experience may be considered in lieu of formal education
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