Responsible for overseeing and managing various QMS sub-systems (e.g. Internal Audits, CAPAs, Risk Analysis), overall GMP compliance, and driving critical process improvements. Ensuring QMS is compliance to MDSAP requirements.

Responsible for the support and compliance of a quality system for cGMP processes to align with the requirements of FDA 21 CFR parts 210 and 211. Assist in establishing a robust quality system with involvement in documentation, training, deviations, CAPA, nonconformances, change management, etc. Additional responsibilities include review and approval of raw and manufactured material based on internal and client specifications, review of risk management for completeness, feasibility and adequacy, support supplier management and the internal/external audit programs.

Key role in the implementation and maintenance of the Quality System and all documentation related to the QS. Responsible for the management of DCRs, ECRs, and NCRs as well as reporting metrics on these areas during site management review. Additional responsibilities include daily review activities of finished good products and certificate of analysis for final release, validation of equipment, and participate in complaint review.

Responsibilities include overseeing the complaint processes including investigation, FDA and EU Vigilance reporting, and closure as well as review and process returns and disposition through the NCMR process and management within the Material Review Board. Participate in internal and third party audits.

Responsible for providing support from a regulated systems perspective for a GMP/ISO manufacturing environment. Activities include batch record review, inspection, and release of finished product and intermediate solutions based on internal or customer specifications; Participate in the Material Review Board for Non-conforming Material Reports (NCMRs); Accountable for incoming complaints and the direction of internal investigations; As well as review, maintain, and generate metrics for process deviations. out of specifications, and product reworks.

Responsible for support, training and technical issue resolution for point-of-care clients, as well as account management to support sales, client contract compliance, and instrument testing/quality control.

Management of schedule for Charles River pharmacy, a critical role in ensuring timely formulations to meet clients’ preclinical study needs and the work of numerous other lab departments.Responsibilities: Provide weekly schedule for pharmacy formulations, daily formulation dispensations, room allocations, and shipments. Report departmental metrics; coordinate pharmacy activities with other departments; provide weekly statistics based on workload and staffing.

Formulate Test Material and other study related items on a daily basis; perform data review of preparations; understand and review study protocols.