• Conduct Environmental Monitoring the production facility
• Perform personnel monitoring to support Aseptic Gowning Qualification
• Incubate and enumerate colony growth and subculture organisms
• Coordinate and manage sample shipments to approved external contract laboratories for microbiological testing, including bacterial or fungal identification
• Review and report data results from external contract labs
• Perform data entry into approved repository
• Perform Microbiological and Environmental Monitoring trending and author reports as per schedule
• Manage bacterial growth media and plate inventories, testing materials, standards, components and consumables to ensure testing execution to planned schedules
• Execute bioburden enumeration assays and endotoxin measurement assays
• Accurately complete documentation and report results, including any potential excursions and non-conforming results to departmental management in a timely manner
• Collaborate with area owners to investigate environmental excursions, and implement corrective actions
• Maintain equipment and instruments and coordinate preventive maintenance and calibrations
• Execute microbiological method qualifications and verifications protocols
• Maintain the QC lab including periodic cleaning of incubators, biosafety cabinets, cold storage chambers, and the lab
• Train personnel in and qualify personnel for aseptic gowning
• Adhere to and promote laboratory health and safety requirements

What we’re looking for

• Familiar with the US, EMA, and ICH regulations and guidance documents including aseptic guidance such as Annex 1
• Good working knowledge of microbiological assays, pharmaceutical microbiology, aseptic technique and performing work in biosafety cabinets or laminar flow hoods
• Experience with aseptic gowning and cleanroom operation activities
• Experience in contamination control strategies
• Good working knowledge of aseptic processing
• Experience with GMP Quality/Compliance systems
• Collaboration skills
• BA or BS degree in Microbiology, life science or biochemistry
• 1-2 years' experience in the pharmaceutical or biotechnology industry in a Microbiology, Quality or Compliance function

What will separate you from the crowd

• Performing cleanroom work in sterile gowning
• Experience with writing SOPs, change controls and lab investigation reports
• Experience with facility qualification activities

What you should know 

• There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing
• The base pay range for this position at commencement of employment is expected to be between $70,000 to $85,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience