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Team Leader, Microbiology

The Team Leader, Microbiology, is responsible for supervising the Microbiology Laboratory, providing technical expertise, leadership, and training to the Microbiology team. The team leader applies technical skills in the training of the micro team members in aseptic procedures, operations/process flow, prioritization, instrumentation, and troubleshooting, as well as in assessing new methodologies and procedures for transfer.

Responsibilities

  • Responsible for prioritizing workload for laboratory analysts, schedule testing according to performance expectations, ensuring test sample results are reported in a timely manner to meet the customer requirements, as well as internal and external communication.
  • Responsible for Microbiology Laboratory personnel training, evaluation, and approval of training records. Provide leadership and coaching to team members and identify training needs and development where required as well as participate in the assessment, hiring, and interviewing of Microbiology staff.
  • Responsible for microbiology analyst’s annual reviews.
  • Acts as the Biosafety Officer for the CL-2 laboratory.
  • Perform timely and effective Investigations (EMR and ERA) for environmental and personnel test results that are out-of-specification, in addition to Microbiology Laboratory Investigations.
  • Responsible for the non-aseptic environmental monitoring program: sampling, read out, investigations and annual trend report.
  • Responsible for the water system microbiology test results, read out, investigations and annual trend reports.
  • Responsible to notify the Sterility Assurance Manager of all non-conformance events (alert and action levels) that occur in the APA, and auditing requirements to support investigations.
  • Responsible for microbiology lab test results that includes but not limited to: Microbial Enumeration Test, GPT, MPT, water system test results, AET, antibiotic assays, biological spore assays, microorganism identification, disinfectant efficacy test result, penetration studies.
  • Ensure that excellent documentation, controls, and capabilities are in place to maintain data integrity, and ensure timely and effective actions are taken
  • Participate and support customer and regulatory audits as a SME in Microbiology.
  • Participate in internal audits, as well as maintain and update relevant SOP’s.
  • Review product specifications and test methods to current USP and customer requirements and propose appropriate updates.
  • Assist Technical Services Team in Microbiological Validation studies by reviewing, providing technical expertise, and executing activities as required included data analysis, preparing report and review.
  • Coordinate testing, documentation, and release of sterility samples with the contract laboratory for aseptic products.

Qualifications and Requirements

  • Sc. in Microbiology
  • Minimum 5 years of hands-on experience working in a microbiology laboratory in a GMP facility and a CL-2 lab.
  • Knowledge of microbiology laboratory techniques, terminology, equipment, and materials.
  • Preferably experience in the identification of microorganisms using the Biolog system
  • Demonstrated knowledge of aseptic processing
  • Knowledge of computerized information systems
  • Highly developed troubleshooting skills
  • Project leadership skills
  • Excellent teamwork skills
  • Working knowledge of GMP, GLP and HPFBI guidelines, sterile ISO-guidelines and safety guidelines
  • Excellent planning, organizational, interpersonal and communication skills (both written and verbal)
  • Demonstrated problem solving skills with focus on RFT

Application Process

Application process: Please send your resume using the form below.

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