Quality Control Associate, Microbiology

4 weeks ago

Thousand Oaks, United States FUJIFILM Diosynth Biotechnologies Full time

The QC Associate, Microbiology is responsible for partnering with management in supporting and maintaining QC microbiological functions for new and existing GMP manufacturing operations. This position will also support facility qualification operations for new GMP manufacturing areas including Environmental Monitoring Performance Qualification (EMPQ) and GMP utilities qualification.

Reports to: Supervisor, QC Microbiology

Location: Thousand Oaks, CA

Travel: Less than 10%

Shift: This role will support a 4 day/10-hour work schedule with Either Sunday – Wednesday, Wednesday – Saturday, Mon, Tue, Thu, Fri shifts. Alternatively, this role can support a 5-day 8-hour shift from Mon-Fri.

Primary Responsibilities

  • Collects and performs non-viable, viable air (active and passive) and surface monitoring and personnel monitoring to support routine environmental monitoring, in-process environmental monitoring, process simulation, aseptic operator qualification and gowning qualification.
  • Performs sampling and testing of GMP utilities such as compressed gases.
  • Documents Environmental Monitoring sampling using LIMS.
  • Executes microbiological assays such as bioburden, endotoxin, gram stain, mold identification, growth promotion and plate enumeration.
  • Reviews Environmental monitoring raw data generated by LIMS.
  • Supports EM data management including data entry, data verification, data download, generation of crystal reports from LIMS to support data trending.
  • Performs routine maintenance including support of calibration and sanitization of lab equipment and lab spaces.
  • Supports QC equipment qualification including implementation of new methods.
  • Revises procedures and forms with guidance from supervisors
  • Supports internal and external inspections and audits.
  • Generates Desigo reports for non-viable particulates testing during in-process environmental monitoring.
  • Tracks and support the calibration of EM equipment such as Climet and SAS.
  • Generates Work Orders for equipment, data entries for material ingress.
  • Coordinates the shipping of isolates for microbial identification.
  • Performs special projects as assigned.


Physical Requirements

  • Subject to extended periods of sitting and/or standing in a laboratory and classified room environment.
  • Ability to lift 50 lbs. and to work in controlled space laboratory required.
  • Ability to use ladders to reach high sampling sites.
  • Ability to reach above the shoulder and bend to be able to gown.


Education and Professional Experience

  • Bachelor’s degree in microbiology, Molecular and Cellular Biology, Biochemistry, or Biology with 0-3 years of experience; or
  • Associate degree with 4+ years of direct laboratory experience; or
  • High school diploma with 6+ years of experience
  • Quality Control experience in the pharmaceutical industry supporting cGMP manufacturing including site qualification and utility validation preferred.


Position Requirements

  • Direct experience is highly desirable in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines.
  • Direct experience is highly desirable in regulatory inspections.
  • Must possess excellent verbal and written communication skills, good interpersonal skills.
  • Experience in cGMP for cell therapy testing is a plus.
  • Must be able to work in controlled environments requiring special gowning.

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