Quality Assurance Manager

About the role

Allied Reliability is seeking a Quality Assurance Manager of Pharmaceutical Operations in Syracuse, NY. The QA manager will oversee assigned staff to monitor the operations and performance of the Quality Assurance team. Ensure departmental operations and documentation comply with standard operating procedures, government regulations, and customer requirements. Ensure company programs comply with regulations, guidelines, and industry standards. Assist in maintaining budget and acting as liaison with both internal and external entities. Assist with recruiting and selection process for department.

Responsibilities

• Manage Quality Assurance Department – Provide guidance and support to supervisor in management of Quality Assurance team including overseeing team performance. Manage department to ensure team members are working toward company and departmental goals. Participate in performance management and other Human Resources related items. Manage operations of department among all company facilities and production shifts. Participate in recruitment and selection process.
• Documentation Review and Approval – Review and approve Production and Quality documentation including but not limited to Batch Records, Deviation Reports, SOP's, Investigative reports, etc., to ensure completeness, accuracy and compliance with procedures, regulatory guidelines, and industry/customer expectations.
• Document Preparation/Revision – Prepare/revise SOPs, sample plans, and other production documents as required. Investigate and write reports, provide status reports and updates per procedure for deviation and investigation reports CAPA.
• Department Representative – Attend internal and external meetings as directed by Department Head to include management meetings, FDA and customer audits and inspections. Provide CAPA updates and input on departmental metrics.
• Acts as Departmental Liaison – Contact customer(s) on quality issues as applicable. May assist with customer and/or supplier audits. Act as liaison internally and cross departments.

Qualifications

• ASQ (CQA, CQI, CQE) beneficial but not required.