Quality Control Analyst II

Quality Control Analyst II Location: Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST. Compensation & Benefits Annual base salary: $70,200–$81,900 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 and moderately complex laboratory testing in support of GMP manufacturing and stability programs. Execute laboratory methods, analyze data, troubleshoot, investigate, and document results. Maintain compliance with regulatory requirements and support continuous improvement initiatives. Conduct 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 protocol execution, sample inventory management, testing coordination, and documentation review. Participate in laboratory investigations (deviations, out‑of‑specification (OOS) and atypical results), identify root causes, and support 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. Qualifications Associate degree, technical certification, military laboratory training, or equivalent education and laboratory experience. Minimum 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 manage multiple priorities. Strong written and verbal communication skills with the ability to work collaboratively across teams and maintain accurate laboratory documentation. Equal Employment Opportunity We offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr