Kelly is hiring a Microbiology Supervisor
for one of our pharmaceutical clients in Irvine, CA
- DIRECT HIRE ROLE!
- Salaried ($105,800-$145,500)
- Client: Teva
- Relocation offered
- Competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.
Responsible for coordinating laboratory personnel and all activities associated with the functional area to ensure that the laboratory operates efficiently and effectively while performing routine and non-routine tasks.
Oversee a team responsible for data generation and review in support of batch releases.
• Generate product testing schedule and coordinate sample receipt from Manufacturing, Stability, and Validations and delivery to the appropriate QC Microbiology Product Testing laboratories.
• Responsible microbiological culture media and reagent receipt, quarantine, testing and release to support laboratory operations.
• Provide technical knowledge, training, and guidance to lab associates for product testing, critical utilities sampling and testing, equipment qualifications, and laboratory control to ensure all processes meet company and regulatory requirements.
• Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
• Review raw data and enter, verify and/or release results with a Laboratory Information Management Systems (LIMS).
• Conduct and document investigations for OOS results, environmental excursions and other laboratory discrepancies as required.
• Directs the investigation of microbiology related in-process, finished product and environmental systems excursions.
• Interact with other departments and area owners to ensure effective and efficient communication of critical information.
• Interface with FDA and other regulatory agencies during Prior Approval (PAI), routine or field complaint inspections
• Implement process validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
• Provides technical support to R&D, Validations, and Engineering.
• Writes and/or reviews environmental data trending reports for clean rooms on a routine and timely basis.
• Writes, revises and approves microbiology department procedures.Qualifications
• BS degree in Microbiology or closely related field.
• 1 years of previous supervisory experience.
• 6 years of laboratory experience associated with the QC Microbiology testing performed in a pharmaceutical company.
• 6 years Experience with Kinetic Chromogenic Lysate and/or Kinetic Turbidimetric bacterial endotoxin test required
• 6 years Experience with Steritest® sterility test apparatus and methods required
• 6 years Experience with Laboratory Information Management Systems required.
• Experience in Terminal Sterilization and Aseptic Manufacturing
• Experience in Equipment and Test Method Validation
• Knowledge of scientific theories, instrumentation and techniques
• Experience with both Microscopic and Light Obscuration Particle Count Tests (HIAC or equivalent) preferred.
• Knowledge of cGMPs, EP and USP requirements and microbiological test methods.
• Knowledge and experience in aseptic processing environments preferred.
• Experience with Isolator Technology used for sterility testing and/or drug product manufacture preferred.