The role of MQA Supervisor is integral to the on-going compliance of the manufacturing and distribution processes. The MQA Supervisor is involved in the following stages of the product life cycle --- manufacturing support, and post-launch maintenance
Supervise the MQA Product Release and Line Inspection groups to ensure the timely inspection and release of product. Identifies roadblocks and escalates issues as necessary to prevent delays.
Ensures solutions and contract manufacturing lots that do not conform to quality standards are fully investigated within the pre-established turn-around timeframe. Supports/leads investigations using root cause analysis tools, and proposing/implementing systemic corrective actions. Implements corrective action efforts associated with Product Release and Inspection activities.
Review, revise and approve procedures and specifications as needed.
Communicates and implements the document/process changes with the department and operations.
Identify, evaluate, select, and against continuous improvement and compliance initiatives.
Write, track and manage performance evaluations, and help to manage the performance of department staff.
Establish, manage and monitor departmental budget and spending against stated variances.
Promote open communications with the department and internal customers.
Interview, hire and support a qualified and diverse department staff.
Institute/Maintain training programs to develop staff.
Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators.
Role has budget responsibility for department spending
Size of Team: Approximately 8 Line Inspectors and 9 Release Coordinators.
Responsibility is limited to Greenville Solutions Facility and associated inspection activities at the Greenville DC(s).
Internal customers/partners: Operations, Distribution, Commercial, Planning, Compliance, Engineering
External customers: Regulatory Agencies and Notified Bodies
Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering
Specialized training in 21CFR211, 21CFR820, ISO 9001:2000, ISO 13485 preferred.
Certifications preferred: CQA
5 years experience in a QA role within an FDA regulated manufacturing or distribution facility required.
Supervisory experience required either in a quality compliance role or an operations/manufacturing role.
Must have experience in incoming and/or finished product inspection experience with use of sampling plans preferred.
Should have experience in a contract manufacturing and/or Distribution Operations arena.
Should have experience with computerized inventory and warehouse systems.
Experience as an internal or external auditor and in conducting investigations is a definite plus.
Should have experience with automated quality documentation systems (e.g. TrackWise, Compliance Wire, Documentum, Change Control).
Experience in leading, conducting and writing investigations