Posted in Other 6 days ago.
Location: Florence, South Carolina
Work Schedule
Other
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Fluctuating Temps hot/cold, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights
Job Description
Summary:
Working with Pilot Plant Management, support daily operations of cGMP guidelines while coordinating manufacturing, cleaning, and maintenance related activities of the Pilot Plant. Monitors all operations of the designated chemical process to ensure safe chemical procedures, quality standards and compliance with regulatory requirements for working with and handling raw materials, production intermediates, and final products. Serves as the SME for assigned area. Makes decisions that require choosing between multiple options or may develop new options to resolve complex problems.
Essential Functions:
Serve as the subject matter expert in area of assigned responsibility, ensuring compliance with all applicable regulatory agencies, as well as company policies and procedures. Write/review/update BOP's / SOP's / DR's or other procedures as the need arises. Apply problem solving skills, in BOP's and field operations. Lead investigations applying problem solving skills, both in the BOP's and in field operations and make recommendations for improving Process Operations. Perform manual and computer operations (PLC) to manufacture chemical intermediates and finished products. Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies. Accurately record and analyze against standards all processing data gathered to ensure operating standards are met. Make approved adjustments as appropriate to maintain process parameters within designated limits. Make recommendations regarding improving process operations. Obtain samples of process streams or products; submit samples to QC Lab or perform tests to determine specific properties; Record/analyze results and take appropriate action. Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as the need arises. Receive and check raw materials and chemical intermediate deliveries and complete appropriate records in accordance with company procedures (BOP's/LOM's/SOP's). Administer, document and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions. Mentor newer Process Techs and assist where applicable in skill completion/assessment as the need arises with all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the vital compliance status required by company and facility standards. Responsible for disposing of any hazardous waste generated in accordance with the company's Hazardous Waste Training but not limited to:
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