ASSOCIATE OPERATOR/FINISHING OPERATOR

Job Description 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.

Qualifications

• 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