Quality Control Analyst II

About the role

Location: This position is based in our Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM-5:00 PM EST.

What you will get

The full-time base annual salary for this position is expected to range between $70,200 to $81,900. In addition, below you will find a comprehensive summary of the benefits package we offer:

• 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).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

What will you do

We are seeking a Quality Control Analyst II to perform routine and moderately complex laboratory testing in support of GMP manufacturing and stability programs. This role combines hands-on laboratory execution with data analysis, troubleshooting, investigations, and documentation activities. The successful candidate will contribute to laboratory operations while maintaining compliance with regulatory requirements and supporting continuous improvement initiatives.

• 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

What we are looking for

• 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 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 preferred
• 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