QC Microbiology Technician

Job Responsibilities:    

• Exemplifies team-oriented behaviors and is willing 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,

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