QC Microbiology Technician

INCOG BioPharma ServicesFishers, IN
1dOnsite

About The Position

The QC Microbiology Technician will work closely with QC Microbiologists and the QC Microbiology Manager to support development and readiness activities for the Quality Control Microbiology lab. The QC Microbiology Technician will perform routine sampling for items undergoing QC testing, perform routine microbiology techniques and assays to generate data needed for product support, and manage day-to-day tasks within the lab including but not limited to consumables ordering, daily instrument calibration/verification, and laboratory waste management. The QC Microbiology Technician will be crucial in helping the lab maintain efficient operation by supporting our Quality Mindset with skills including attention to detail, on time delivery, and commitment to Quality excellence. Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC Microbiology Technician will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The QC Microbiology Technician will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.

Requirements

  • 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.

Nice To Haves

  • Working knowledge of laboratory instrumentation and methods supporting endotoxin and bioburden analyses.
  • Demonstrated experience with environmental monitoring,
  • Experience with Continuous improvement, Six Sigma, and/or Lean principles.

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.
  • 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 routine environmental monitoring and collection of utilities within facility.
  • Performs common microbiology testing on incoming media and utility samples adhering to best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
  • 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.
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