ASSOCIATE OPERATOR/FINISHING OPERATOR

The Manufacturing (Finishing Operations) Associate Operator works in a compliant, efficient, effective and safe manner in the areas of Inspection and Packaging. Responsible for the visual inspection (manually or semi-automated methods), Bulk Packaging and Secondary Labeling and Packaging of nab (nanotechnology albumin bound) and cytotoxic/antineoplastic products in accordance with batch record specifications. Ensures proper systems, equipment, materials, and other resources are in place to meet production demands through hands-on involvement and liaison with supervision. Ensures products are inspected/processed/handled and packaged in complete accordance with all cGMP, SOP, and Batch Records. This position may require overtime, shift work, and flexibility in scheduling of “set” shift hours at times, based on production or department needs. 

ESSENTIAL FUNCTIONS
• Maintain manufacturing areas that are compliant, efficient, effective and safe
• Perform major activities in each of the following areas:
o Inspection – Manually or Semi-Automatically inspects filled products and media for visual defects, container/closure integrity, particle matter or other anomalies. Receive, store and verify products into Inspection. Complete Batch Record documentation
 Load-Unload vials of Cytotoxic filled vials from turntables to trays to pallets
• Involves standing for periods up to 3-4 hours in duration
o Packaging - Receive, return and reconcile packaging components and product. Clean packaging area. Perform hand packing operation, container cleaning and label removal. Complete Master Packaging Record and associated documentation.
 Operates Labeler and Cartoning machinery
• Manual inserts vials and patient inserts into formed cartons
• Operates case sealing machinery
• Involves standing for periods up to 3-4 hours in duration
• Utilizes pallet jacks
• Follows SOPs and cGMP requirements under direct supervision
• Communicates effectively with peers, follows detailed instructions/procedures, and demonstrates strong teamwork
• Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively
• Works with supporting departments to meet production timelines as directed by supervision
• Ensures proper operational supplies and consumables are on hand to meet production requirements
• Uses/interfaces with computers to perform GMP tasks, complete training and communicate through e-mail
• Assists with process optimization projects and programs as directed by supervision
• Perform other duties as assigned.

• Requires a High School Diploma or equivalent, AA degree preferred, with a minimum of 1-2 years related experience in a regulated setting, preferably in a manufacturing environment.
• An equivalent combination of education, experience and training may substitute.
• Must have good understanding of cGMP requirements.
• Must have a proven technical understanding of processes system operations, equipment and problem solving

All your information will be kept confidential according to EEO guidelines.