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Manufacturing Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 07/19/2019 Job Type: Scientific Job Number: JN -072019-25245
Duties:
  • This manufacturing associate position is responsible for the production of recombinant antigens, peptides and/or buffers.
  • Provides necessary support for all production activities associated with the Antigen production work.
  • Operates complex antigen production equipment
  • Participates in equipment and process qualification and troubleshooting
  • Maintains the production areas and all equipment in clean and orderly operating condition in accordance with cGMP, ISO and company quality and safety standards.
  • Responsible for 5S duties related to maintenance of the manufacturing labs.
  • Maintain safe work environment complying with biohazard and chemical safety procedures.
  • Performs all manufacturing operations under cGMP/ISO requirements.
  • Adheres to valid manufacturing procedures and documentation.
  • Performs legible, clear and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process.
  • Completes all training documentation within a pre-defined timeframe.
  • Analyzes in-process samples generated from production activities as needed.
  • Completes all required documentation for proper traceability of a production lot.
  • Operates a variety of basic lab equipment (pH meters, balances, centrifuges, and spectrophotometers) as well as more sophisticated equipment such as multiple fermenter.
  • Performs standard laboratory operations including dispensing chemicals, volumetric and gravimetric measurements, making accurate dilutions and preparing buffers and solutions.
Skills:
  • Experience following SOPs
  • Very good verbal and written communication skills
  • Knowledgeable in SAP is a plus
  • Computer knowledge required. Experience with Word and Excel
  • Strong attention to detail, able to document work accurately, excellent organizational skills
  • Experience with preparation of reagents following manufacturing instructions
  • Deliver quality products and services on time to all customers, internal and external.
  • Must be attentive to detail and effectively manages time.
  • Independent thinking and considers the overall impact of our product for internal and external customers.
  • Monitor processes and products to identify opportunities for continuous improvement.
  • Track and order raw materials for department from the warehouse.
  • Restock lab drawers
Occupational Demands:
  • Able to lift and push up to 35 lbs.
Education:
  • Associate or Bachelor s degree in one of the biological or physical sciences
  • 1 to 3 years' of experience in a GMP environment
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