Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Vacaville

Description

Leader and Subject Matter Expert (SME) in Environmental and QC Microbiology topics. Technical expertise in Microbiological testing of Genentech products and microbial control systems.
Perform a broad variety of basic and moderate complex laboratory tests in support of Microbiology Laboratory Technical Team operations.
Microbiology SME at internal and external Audits, Regulatory Inspections, Support to Annual Product Reviews (APQR’s) and product Biological License Applications (BLA’s) reviews. 
Actively participate in projects (global and local) and process improvements initiatives. May own or lead projects at the Network Level.
Project Management; must plan and execute method transfers, method suitability tests, and method validations. Work to meet schedules, timelines and deadlines.
Receive, provide, and coordinate training activities.
Support Quality Systems (i.e. Microbiology discrepancies and Investigations, CAPA’s, Change Records). Identify and troubleshoot technical microbiological problems and execute root cause analysis and Case by Case assessment of Bioburden or product Action limit excursions.
Organize and manage meetings and deliverables, with strong communication and documentation skills.
Work with internal departments and outside vendors, collaborators and partners concerning microbiology projects and commitments.
May perform routine laboratory maintenance activities including equipment, materials and reagents preparation.
Ensure GMP and Microbiology scientifically sound ideas are applied throughout operations.
B.S. degree (preferably in Microbiology) or any relevant scientific discipline and five (5) years of experience in commercial quality control, or Master’s degree plus three years of experience in Quality Control; Ph.D. Degree plus two years of experience in QC.
Basic knowledge of scientific theories, principles, and techniques used in microbiological test procedures. Routinely exercises sound judgment, reasoning and problem solving.
Strong communication, coordination and leadership skills. Strong negotiation, influence, and decision-making skills in order to meet local, network, and global objectives and initiatives. 
Capable of working independently or under moderate supervision.
Must be able to plan short and long-term priorities and manage multiple projects and teams.

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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