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Aseptic Manufacturing Technician

Company: PYRAMID Laboratories, Inc.
Location: Costa Mesa
Posted on: May 3, 2021

Job Description:

Job Description POSITION SUMMARY: Under general supervision, perform various manufacturing related activities for a cGMP compliant aseptic Fill/Finish operation applying standard practices, techniques and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks. Other responsibilities include monitoring, troubleshooting, maintaining and validation of equipment required for related manufacturing operations including support systems, as applicable. PRINCIPAL DUTIES: Familiar with related cGMP procedures and requirements, as directly related to the position. Ensure that appropriate procedures and processes are utilized without unauthorized modifications. Ability to set-up, operate, and maintain various manufacturing equipment as required for a cGMP compliant Fill/Finish operation. Perform aseptic filling for drug products in vials and pre-filled syringes. Perform sanitization of clean rooms, and sterilization and depyrogenation of manufacturing equipment. Perform all duties and manufacturing activities according to the applicable guidelines, i.e. FDA, GMP, ICH, etc. Ability to problem solve and assist in technical decision-making commensurate with the level of experience. Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs. Performs other related duties and responsibilities as assigned. MINIMUM QUALIFICATIONS/REQUIREMENTS: Minimum one (1) year of experience in a cGMP environment. No degree required. Must have experience working in Grade A environment with filling machines. Demonstrated ability to work under general supervision; exhibit skills to coordinate projects on various levels. Excellent oral and written communication skills are required. Company Description PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider for the pharmaceutical industry.

PYRAMID offers a wide array of services for all phases of drug development, including:

Aseptic Filling Formulation & Process Development Lyophilized Product Formulation & Cycle Development Product Process Validation Clinical and Commercial Vial & Syringe fill / finish Clinical and Commercial Lyophilization batches Labeling & Packaging Analytical Quality Control Laboratory Services Analytical Method Development & Validation API & Drug Product Stability Studies

Keywords: PYRAMID Laboratories, Inc., Costa Mesa , Aseptic Manufacturing Technician, Other , Costa Mesa, California

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