Quality Control Analyst I (GMP)

TL;DR

Quality Control Analyst I (GMP): Performing routine and moderately complex laboratory testing for GMP manufacturing and stability programs with an accent on environmental monitoring, data analysis, investigations, and compliant documentation. Focus on executing cleanroom testing, identifying root causes for quality events, maintaining GMP records, and supporting continuous laboratory improvement.

Location: Onsite in Walkersville, Maryland, United States, Monday–Friday, 8:00 AM–5:00 PM EST

Salary: $61,200–$71,400 annual base salary, plus performance-related bonus and benefits.

Company

hirify.global is a life sciences and biotechnology manufacturing company with sites across five continents that supports the development and production of medicines.

What you will do

• Perform routine and moderately complex testing of in-process, release, environmental monitoring, and stability samples.
• Conduct viable and non-viable environmental monitoring, surface sampling, personnel monitoring, and utility monitoring in classified cleanrooms.
• Review, analyze, and interpret laboratory data for accurate and timely reporting.
• Support GMP stability programs through protocol execution, sample inventory management, testing coordination, and documentation review.
• Investigate deviations, OOS/OOT results, environmental monitoring excursions, and atypical results while supporting corrective actions.
• Maintain GMP documentation, train laboratory personnel, and support sample management, inventory control, equipment maintenance, and external laboratory coordination.

Requirements

• At least 2 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment.
• Associate degree, technical certification, military laboratory training, or equivalent laboratory experience; relevant GMP experience may substitute for formal education.
• Working knowledge of analytical laboratory techniques, aseptic practices, cleanroom behavior, contamination control, and GMP operations.
• Familiarity with GMP regulations, data integrity, quality systems, and laboratory compliance requirements.
• Experience supporting laboratory investigations, deviations, OOS/OOT results, CAPAs, or environmental monitoring excursions.
• Strong analytical, organizational, troubleshooting, documentation, communication, and collaboration skills.

Culture & Benefits

• Full-time onsite work with a Monday–Friday schedule.
• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan, life insurance, and short- and long-term disability insurance.
• Employee assistance programs and paid time off.
• Collaborative, accountable, excellence-focused environment supporting life sciences innovation.