We are currently looking for a Full-Time
Quality Control Manager to join our teamin our
Plainville, CT site. The QC Manager will work closely with other departments and must be able to collaborate effectively with others to ensure their quality control needs and specifications are met. This is a key position in our organization and the successful candidate must be able to communicate strategies clearly and effectively internally. The ideal candidate will be comfortable working in a fast-paced environment, can manage multiple site-specific projects, and feel comfortable leading when necessary.
Primary Responsibilities:The primary responsibilities for this position include:
- Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring end-to-end compliance of incoming, in-process and routine operations and testing including environmental monitoring, water testing, stability, production, and incoming material release.
- Collaborate with other departments to resolve quality-related matters.
- Author, edit, review, and approve documents, including SOPs, work instructions, deviations, CAPAs, change controls, protocols, and environmental monitoring reports.
- Responsible for QC (Microbiology and Chemistry) administration, scheduling, and budgeting.
- Ensure compliance with regulatory standards and industry best practices (GxP).
- Oversee and adhere to global quality metric goals and plant metrics.
- Requisition and procurement of laboratory supplies related to QC laboratories and production support.
- Provide ILT (Instructor-Led Training) to QC team members on laboratory documents, including SOPs, WINs, and protocols - ensuring all staff are properly trained and qualified for assigned tasks.
- Provide support, leadership, and development of QC team members.
- Oversee plan and execution of product validation and stability studies, ensuring accurate data verification, reporting, and compliance with regulatory requirements.
- Ensure calibration, maintenance and operation of lab instrumentation, including balances, pH meter, UV/vis spectrophotometer, and other analytical equipment as necessary.
- Serve as primary subject matter expert during internal and external audits (e.g. FDA, Health Canada, Notified Body, and supplier audits).
- Foster a culture of quality and continuous improvement within the team and other departments.
- Other duties as assigned.
Skills and Experience:- BS / BA in life sciences, biology, chemistry or related field preferred
- This position requires minimum 5 years of progressive management experience in a laboratory setting with increasing responsibilities in Pharmaceutical or GMP environment.
- Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines is required.
ALK offers:- Excellent benefits including medical, dental, and vision
- 401(k) plan with generous employer contribution
- 12 company-paid holidays per year
