Quality Control Analyst I

Pay

The full-time base annual salary for this position is expected to range between $61,200 to $71,400.

Schedule

The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

Benefits

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance
• Short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

Responsibilities

• Perform routine sampling and testing of environmental monitoring (EM), utilities, raw materials, in-process materials, finished products, and stability samples in accordance with approved procedures and cGMP requirements.
• Execute assigned laboratory testing and support activities within established timelines while maintaining accuracy, quality, and compliance.
• Accurately document, review, and report laboratory data in compliance with Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
• Conduct environmental monitoring activities within classified manufacturing and laboratory environments, including viable and non-viable monitoring, surface sampling, and personnel monitoring as applicable.
• Support sample receipt, handling, storage, inventory tracking, and shipment coordination with external testing laboratories.
• Support day-to-day laboratory operations, including housekeeping, inventory management, material stocking, and routine equipment care.
• Identify, document, and escalate deviations, atypical results, out-of-specification (OOS) results, or compliance concerns in accordance with quality procedures.
• Participate in training activities to expand technical proficiency and support validation, continuous improvement, or innovation projects as assigned.

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 performing routine laboratory testing and sample handling activities in a GMP-regulated environment.
• Experience performing environmental monitoring activities, including viable and non-viable air sampling, surface sampling, personnel monitoring, or utility sampling preferred.
• Working knowledge of aseptic technique, contamination control principles, laboratory practices, and cGMP requirements.
• Understanding of Good Documentation Practices (GDP), ALCOA+ principles, and data integrity requirements.
• Ability to accurately follow written procedures, maintain laboratory records, and execute testing with attention to detail.
• Strong organizational and time-management skills with the ability to manage multiple testing priorities under supervision.
• Effective written and verbal communication skills and the ability to work collaboratively within a quality and manufacturing environment.