QC Manager

ALK-Abello, Inc•Plainville, CT

1d•$115,000 - $125,000•Onsite

About The Position

ALK is seeking a full-time QC Manager for its Plainville, Connecticut site. The QC Manager oversees daily operations in the Chemistry and Microbiology laboratories and works closely with other departments to meet quality-control needs and specifications. The role calls for clear communication of strategies, effective collaboration, and the ability to lead in a fast-paced environment while managing multiple site-specific projects. The manager is responsible for laboratory compliance, documentation, administration, scheduling, budgeting, staff training and development, laboratory equipment, and product validation and stability studies. The role also serves as the primary subject matter expert during internal and external audits and promotes quality and continuous improvement.

Requirements

Minimum 5 years of progressive management experience in a laboratory setting, with increasing responsibilities in a pharmaceutical or GMP environment.
Strong chemistry knowledge.
Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA, and ICH guidelines.

Nice To Haves

BS/BA in life sciences, biology, chemistry, or a related field preferred.

Responsibilities

Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring compliance for 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.
Manage 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 procure laboratory supplies related to QC laboratories and production support.
Provide instructor-led training to QC team members on laboratory documents, including SOPs, WINs, and protocols, and ensure staff are trained and qualified for assigned tasks.
Provide support, leadership, and development for QC team members.
Oversee the planning and execution of product validation and stability studies, ensuring accurate data verification, reporting, and regulatory compliance.
Ensure calibration, maintenance, and operation of laboratory instrumentation, including balances, pH meters, UV/vis spectrophotometers, and other analytical equipment as necessary.
Serve as the primary subject matter expert during internal and external audits, including FDA, Health Canada, Notified Body, and supplier audits.
Foster a culture of quality and continuous improvement within the team and other departments.
Perform other duties as assigned.