Job description

Role and Responsibilities

Duties:

• To ensure that microbiological testing complies with both GLP and GMP and meets all requirements as per the company’s SOPs
• Functional and Technical Expertise: Possess an understanding of the latest microbiology theories and research initiatives and make recommendations internally about any related changes to current methods and working practices
• Carry out all required testing following appropriate aseptic techniques
• Support value streams in the identification and implementation of corrective actions and increase the knowledge of good hygiene and microbial control practices.
• May be requested to write procedures or guidelines for the use of analytical equipment and to describe Laboratory working practices
• To have a sharp eye for detail and is readily able to identify procedural or GMP errors
• When needed, required to write procedures and / or reports for Laboratory working practices
• Work with plant personnel to ensure that relevant processes and facilities also are microbiologically acceptable
• Ensure compliance with the laboratory Quality Management system
• Maintain the laboratory budget
• Order laboratory supplies and maintain inventory up to the lab needs
• Auditing plant equipment and facilities to determine conditions are favorable for microbial growth
• Provide support to QA and plant to implement changes in plant procedures, equipment, or facilities as needed
• Maintain trends of information on Controlled Manufacturing Environment failures
• Support manufacturing by analyzing manufacturing product lines to determine how or where, within the manufacturing or inspection process, the root cause of non-conformances or customer complaints exist
• When needed, prepare written protocols
• Perform micro testing for coliforms, E coli, Coliforms, TPC, Y&M in accordance with SOP
• Collect and organize production samples and check for discrepancies against specs
• Support continuous improvement of environmental controls by performing real time risk assessments in classified areas as directed by the Lab Director/ FSQA Manager
• Prepare and conduct multiple laboratory tests
• Perform Environmental monitoring tasks
• Review and evaluate raw data for acceptability of products/ raw material
• Perform routine calibration
• calibrates laboratory equipment clean laboratory work environment
• Troubleshooting, cleaning, and maintaining laboratory equipment and supplies
• Conduct sample Tracking
• In charge of maintaining Chains of Custody
• Conduct Microbiology Proficiency Test as required
• General maintenance of the laboratory including monitoring stock, quality control checks, record management

Qualifications and Education Requirements

• BS in Microbiology or closely related field
• Strong English communication skills (read, write, and speak)
• Preferably 6 months of relevant experience in industry or aseptic processing experience
• Knowledge of molecular microbiology techniques including PCR, no experience required
• Capability of working independently and with limited supervision, working with others as a member of a team
• Ability to operate autoclaves, dishwashers, computers, analytical equipment
• Ability to work around lab equipment noise
• Willingness to work flexible hours, including overtime and weekends (occasionally)

Job Type: Full-time

Pay: $50,000.00 - $53,000.00 per year

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Gilroy, CA 95020: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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