Team Leader, Quality Control

Job Description

The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, and act as the point person on CMC Teams and validation projects. Responsibilities include reviewing and reporting test results related to validation protocols, supporting method development and optimization for all microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, and Bioburden, and suggesting and implementing new technologies and equipment for microbiological testing.

• A four‑year degree in science, preferably in Biology or Microbiology, with a minimum of 8 years’ experience in the pharmaceutical industry.
• Experience with the execution of test methods for sterile and non‑sterile drugs, raw materials, components, and in‑process testing, including methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters.
• Critical thinker able to identify issues and work quickly to resolution with minimum supervision.
• Capable of managing and coordinating multiple priorities in a dynamic environment while maintaining a professional demeanor.
• Understanding of common microbiological test instrumentation.
• Excellent organizational, planning, and scheduling skills.
• Good verbal and written communication skills.
• Good interpersonal skills and ability to work effectively in a team environment.
• Commitment to continuous improvement in all areas.
• Ability to work safely and encourage safe practices.
• Experience with LIMS systems, Trackwise or similar electronic documentation systems, and SAP.

• Coordinate and support Tech Services Projects, including method validations and optimizations, and new technologies and equipment.
• Assist in the identification of new microbiology testing technologies and equipment to meet evolving regulatory requirements.
• Support regulatory audits.
• Write protocols and execute method verification/validation/qualification/transfers.
• Write and execute laboratory investigations for out‑of‑specification and out‑of‑trend results.
• Serve as micro­biology point person for higher‑level meetings and projects such as CMC Team support.
• Write documents (SOPs, specifications, technical reports).
• Execute and oversee instrument qualification as necessary.
• Implement continuous improvement activities to maximize available resources.
• Write change controls and work orders for systems and instrumentation changes.
• Review data as needed utilizing LIMS, SAP, and SLIM.
• Troubleshoot technical procedures, methodology, and instrumentation.
• Data entry for testing results following GMP regulations.
• Review test results for other analysts.
• Train new analysts and document training.
• Provide technical support to new analysts.
• Participate in non‑routine projects, validations, and method development to meet departmental and individual goals.
• Review SOPs, product specifications, and controlled forms to comply with USP, EP, JP, and CP regulations.
• Maintain laboratory operations in compliance with industry regulations.

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult‑to‑treat psychiatric and neurological disorders. A fully‑integrated, global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Alkermes is an E‑Verify employer.

Mid‑Senior level

Full‑time

Quality Assurance