WHAT WE'RE LOOKING FOR:

The Manufacturing Support for QA (also known as IPQE internally) is a specialized role responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Covidien requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Writes OOS and minor investigations. Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. The position routinely interfaces with various personnel from Formulation, Filling, Sterilization, Packaging, Laboratories, Facilities and QA. This position is on 2nd shift, 1pm - 9:30pm (shift start time may vary) M- F with occasional rotating weekends.

YOUR ROLE:

• Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
• Perform required QA inspections; i.e Sample defect detection
• Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as, area inspections pre/post activity.
• Ability to participate in internal audits, as requested.
• Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
• Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling
• Ability to support the QA label release functions on an as needed basis
• Attend daily operations staff communication meetings
• Assist personnel in the generation of operations/packaging area related exceptions
• Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
• Have the ability to support minor exceptions
• Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.