Quality Control Analyst II

About the role

The full-time base annual salary for this position is expected to range between $70,200 to $81,900.

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

Requirements

• Average of 3 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
• 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

Qualifications

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.

Skills

• Strong analytical, organizational, troubleshooting, and problem-solving skills
• Strong written and verbal communication skills
• Collaboration, Accountability, Excellence, Passion and Integrity

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)

Pay

The full-time base annual salary for this position is expected to range between $70,200 to $81,900.

Schedule

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