QC Microbiology Technician

2 days ago

Fishers, United States INCOG BioPharma Services Full time

Responsibilities


  • Exemplifies team-oriented behaviors, and willingness to act as both a facilitator and a contributor to special projects as needed. Opportunities for growth and cross training will be available.
  • Sets deadlines and prioritizes tasks for self, team members, and stakeholders. Reviews and approves work performed by coworkers for accuracy and alignment with procedures.
  • Collaborates internally to resolve quality non-conformance events regarding facility, in-process, finished, and released.
  • Supports QC Microbiologists and QC leadership in establishing the new GMP QC Microbiology Laboratory.
  • Maintains a constant state of safety and inspection-readiness in the QC microbiology laboratory.
  • Holds self-accountable for rigorous scientific and quality work standards.
  • Performs sampling of components, raw materials, in-process samples, finished product samples, and stability samples.
  • Performs routine environmental monitoring of facility.
  • Performs common microbiology testing on incoming components, raw materials, in-process samples, finished product samples, and stability samples adhering to best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
  • Performs conventional laboratory procedures such as weighing on analytical balances, glassware wash/prep, daily equipment calibrations, and peer review of test parameters and reagent preparations.
  • Supports testing related to validation protocols, laboratory studies, and cleaning validations.
  • Performs routine preventative maintenance on QC lab instrumentation as needed using written SOPs or assists vendors with access to systems/materials when vendor performs maintenance.
  • Performs troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS).
  • Provides support during laboratory investigations.
  • Manages Laboratory waste while adhering to Environmental, Health, & Safety standards required in a GMP lab.
  • Supports manufacturing process control & process improvement projects.
  • Diligently maintains laboratory documentation to ensure organization and regulatory compliance.
  • Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.
  • Thrives in a team environment, pulls for the team, and can work autonomously with strong self-management and organizational skills.
  • Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
  • Upholds customer-centric mindset.

Qualifications


  • Bachelor’s degree in science (Chemistry or Biochemistry preferred) or equivalent related experience.
  • Strong math and documentation skills.
  • Strong oral and written communication and interpersonal interaction skills.
  • Ability to work in a highly regulated environment.
  • Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).
  • Working knowledge of laboratory instrumentation and methods supporting endotoxin, sterility, and bioburden analyses.
  • Demonstrated experience with environmental monitoring,
  • Experience with Continuous improvement, Six Sigma, and/or Lean principles.
  • Experience in an isolator-based aseptic drug product manufacturing facility.
  • Experience performing container closure integrity testing (CCIT).

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