Quality Engineer - Microbiology

Actalent • Irvine, CA

141d • $35 - $42

About The Position

Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. Performs validation, technology transfer, and troubleshooting. Writes policy procedures for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.

Requirements

• Quality engineering
• Cleanroom monitoring
• Sterilization process
• Equipment requalification
• Medical device quality control
• Microbiology
• Bachelor of Science, Engineering or related subject with 3-5 years' experience in a quality or technical discipline
• Ability to work independently with minimal supervision
• Judgment in applying professional expertise
• Understanding and application of procedures and concepts of own discipline

Responsibilities

• Coordinate microbiological and/or chemical testing.
• Release product and test for validation protocols.
• Perform organism identification.
• Perform technical review of batch filling records to ensure quality of aseptic processes.
• Read and interpret microbiological cultures and other related tests including environmental monitoring, sterility tests, growth promotion, microbial limits tests, and antimicrobial effectiveness tests.
• Perform validation, technology transfer, and troubleshooting.
• Write policy procedures for quality initiatives.
• Review and approve environmental monitoring data and laboratory equipment and records.
• Prepare process and status reports.
• Assign and monitor document numbers and review documents for accuracy and completeness.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees