Aseptic Manufacturing Technician
Company: PYRAMID Laboratories, Inc.
Location: Costa Mesa
Posted on: May 3, 2021
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
PYRAMID offers a wide array of services for all phases of drug
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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