TEMP Manufacturing Operations Associate

Manufacturing Operations Associate

Manufacturing Operations Associates in our Commercial Manufacturing Division are the heart and soul of our organization as they are responsible for the manufacturing of Provenge (Sipuleucel-T) product in a clean room environment. Provenge is manufactured using the patients' blood, personalizing the treatment.

This role requires on-site presence at our Seal Beach, CA location.

Responsibilities

• Works with other Manufacturing Operations Associates utilizing current good manufacturing practices (cGMPs) to aseptically manufacture commercial products using Standard Operating Procedures (SOPs).
• Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation. Escalates processing and equipment issues as needed.
• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Rigorously adheres to SOPs and cGMP regulations to accurately complete paper and electronic records associated with commercial manufacturing.
• Reviews in-process cGMP documentation for completeness and accuracy.
• Unpacks and checks materials received against specifications, maintains records of materials used and rejects unsatisfactory items when necessary.
• Prepares products for final shipment and maintains records of products shipped.
• Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
• Helps drive the safety-first culture
• Applies job skills and company policies and procedures to complete a narrow range of tasks.
• Works on assignments that are simple in nature, escalates issues when required, and making routine recommendations.
• Normally receives general instructions on routine work, detailed instructions on non-routine and new assignments.
• Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs.
• Other duties as assigned

Qualifications

• High School Diploma
• Associates/Technical/BA/BS degree in Science.
• No prior industry experience required.
• Experience in medical device, pharma or biotech preferred.
• Must be able to read and understand quality documents.
• Must be able to read, write and communicate fluently in English