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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.

This is a 2nd shift position, hours are 3:00pm-11:30pm. Shift differential will be discussed.

Essential Job Functions:

·       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.

Special Job 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.

·       Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).

Additional Preferences:

·       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).

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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