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Plant QA Microbiology Scientist (Medical Device) JLK

Location: Los Angeles County, CA
Job # 1770705
Date Posted: 12-10-2012

Veracord is a consulting firm that supports Life Science companies with a wide range of needs related to Quality, Manufacturing, Validation & Compliance. Our client located in the Southern, CA area has an immediate opening for a Plant QA Microbiology Scientist.


 
This position is with a Fortune 100 Medical Device Company in the Los Angeles, CA area.
 
Please email resume to julie@veracord.com
 
Responsibilities

  • Support the Microbiology laboratory for Plant Quality Assurance to meet site quality standards. 
  • Leverage Microbiology expertise to lead projects in microbiology QA lab including method validation, method suitability troubleshooting, and data transfer from R&D to commercial QA/QC labs.
  • Support, provide recommendations and implement Non-Conformance Report (NCR)  and lab investigation corrective actions to support a compliant laboratory.
  • Qualify lab equipment and support equipment calibration, preventive maintenance, and service plans.  Perform appropriate training of laboratory employees in their job functions, and provide quality systems and task training.
  • Provide oversight and assist activities of more junior personnel as required by laboratory management.
  • Review technical problems and procedures within the laboratory and recommend solutions to problems or changes in procedures.
  • Write SOPS, investigation reports, study protocols, validation and suitability reports, and summary reports.
  • Work with laboratory service vendors to establish service agreements and support investigation or trouble-shooting activities as needed.
  • Assure compliance with all US (e.g. FDA Guidelines, USP, cGMP) and compliance requirements (cGMP and Quality Systems) as microbiological testing.

 
Required Experience

  • BS in Microbiology, Biology or closely related field plus a minimum of 7+ years of work experience in a Quality Assurance/QC Microbiology laboratory
  • Experience with developing and validating microbiology-based methods and pharmaceutical microbiological techniques
  • Direct experience in the Pharmaceutical, Personnel Care and/or OTC industry in the field of QA Microbiology
  • Familiarity with USP
  • Knowledge and competency in application of FDA and other required regulations
  • Hands on Experience with USP Microbial Limits testing and identification of microorganisms and interpreting the results
  • Experience writing, modifying, and revising SOPs
  • Strong attention to detail, sense of urgency, and ability to work independently
  • Excellent written and oral communication skills
  • Good organizational skills for leading teams and communicating timelines
  • Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat

 
Preferred Experience:

  • Knowledge ISO
  • Current experience with a variety of microbiological tests of raw materials, in-process materials and finished products
  • Current experience with water testing (USP Purified water), Environmental monitoring, biological indicator testing, and isolate identification (Vitek Microbial Identification System)
  • Experience with knowledge of calibration and measuring performance of microbiological testing equipment.
  • Experience with training laboratory personnel is highly preferred.  Experience with SAP and LIMS.

 
Please email resume to julie@veracord.com

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