Hours: 11pm- 7:30am Monday through Friday
Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
- Ensures that all necessary production documentation (batch production records) and associated SAP transactions are performed to ensure that all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation’s, etc.
- Issue work orders and contact outside vendors for parts or repairs. Participate in the execution and co-authorship of Validation protocols.
- Ensures all necessary production documentation (Filling records/Packaging records) and associated SAP transactions are performed in a manner that ensures all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation’s, etc.
- Depending upon primary focus of position, oversees work groups which conduct aseptic filling operations or Diagnostic Packaging operations. Is responsible for the accuracy, quality and timeliness of multiple daily Filling/Packaging/Label Printing operations. Keeps Area Manager informed of product and production schedule status, particularly of significant observations and potential production delays. Ensures that Filling/Packaging/Label group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO). Serves as a technical resource and mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance.
- Supervises the review of completed production paperwork for completeness and accuracy. During the review process, ensures all in process testing steps performed and documents during the production operation meet all required specifications. Supervises and reviews SAP transactions performed for production operations to ensure the completeness and accuracy of the transactions performed.
- Coordinates Filling/Packaging schedule, Schedules production lines to ensure all available manpower is deployed to meet fill and packaging schedule requirements. Individual is skilled in the operation of all automatic and semi-automatic filling, labeling, and Packaging/warehouse equipment to ensure personnel coverage is assigned as required to meet all production requirements.
- Individual will assist in training of Diagnostic Tech Specialist and Diagnostic Technicians for Filling/Packaging/Label printing operations.
- Ensures Inspection of products for defects and conformance to quality standards and applicable SOPs is performed correctly and accurately and ensures all required in-process product checks are performed as required.
- Understands GMP, QSR, ISO and RMS Quality regulations and ensure that all production operations are performed in a manner that meets these requirements. Ensures all production operations conform to quality standards and applicable SOPs and meet all applicable quality requirements
High School Diploma or GED required
Associate's Degree preferred
5 year experience in supervising filling, packaging, operations, preferably in a pharmaceutical or medical device industry required
7 year previous experience in supervising filling, labeling or warehouse operations in a pharmaceutical or medical device industry preferred
Equivalent combination of education and work experience accepted