Supervisor, QC Microbiology

2 weeks ago


Los Angeles, United States BioPhase Solutions Full time
Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Supervisor, QC Microbiology to work for a Greater Los Angeles area biotechnology company.
Salary: $100-120k depending on experience Responsibilities:
  • Supervision of all QC Micro laboratory testing
  • Conduct performance management of direct reports and have regular development discussions
  • Represent the group in interdepartmental and global meetings
  • Sustain environmental monitoring program and on-time release of product lots to patients
  • Support the optimization of the aseptic gowning training and qualification program
  • Support internal and external audits
  • Maintain and support of QC Microbiology Associate training
  • Assemble reports on findings from cGMP facility/utilities, as needed. Implement corrective action plans when necessary and frequently update management on environmental trends
  • Complete routine record review of test data and related documents for in-process and routine environmental monitoring testing, drug product release. Generation of CoAs for product release
  • Develop, revise and review SOPs, qualification/validation protocols and reports
  • Support EM/UM excursions investigations as Subject Matter Expert (SME) on EM/UM.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
  • Provide updates at daily and weekly meetings
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Other duties as assigned
Qualifications:
  • Master’s Degree with 3+ years of experience, Bachelor’s Degree with 5+ years of Microbiology experience, or High School Degree with 9+ years of Microbiology experience
  • Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
  • Minimum of 5 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
  • Minimum of 3 years’ experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, endotoxin testing and sterility testing of final product.
  • Candidate should be well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to be flexible with schedule, and work overtime as needed
  • Working knowledge of SOP writing and SOP change request is a plus
  • Able to follow instructions and SOPs precisely and able to make/keep accurate documentation
Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities

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