Associate Microbiologist, 2nd shift

INCOG BioPharma Services•Fishers, IN

12d

About The Position

The Associate Microbiologist will operate with a Quality Mindset in all aspects of their role, emphasizing attention to detail, on-time delivery, and efficiency. They will contribute to process-critical Quality Events (such as Laboratory Investigations, CAPAs, Deviations, and Continuous Improvements). The Quality Control Associate Microbiologist will demonstrate strong problem-solving skills, including the ability to define issues, gather data, establish facts, and draw valid conclusions. Excellent written and oral communication skills are essential, with the ability to clearly and concisely explain complex topics to diverse audiences. The Associate Microbiologist will exhibit strong interpersonal skills, fostering productive cross-functional relationships across the organization. They will excel in a dynamic, fast-paced team environment while also working independently with robust self-management and organizational abilities. Additionally, they will show a proven capacity to drive positive outcomes within the QC Microbiology team. This is a 2nd shift position.

Requirements

B.S. in a scientific field (e.g., Biology, Microbiology, Biochemistry) or 3-4 years of equivalent industry experience
2+ years of experience in microbiological testing.
Familiarity with regulatory agencies and documentation (e.g., FDA, EP, JP).
Strong computer skills and experience with laboratory data systems.

Nice To Haves

Advanced degree in microbiology or related field.
Experience with microbiological testing of pharmaceutical products.
Background in an aseptic drug products laboratory.
Knowledge of Kaizen, Six Sigma, and/or Lean principles.
Experience in an isolator-based aseptic drug product manufacturing environment.
Project management experience.

Responsibilities

Play a key role in building and enhancing the QC Microbiology Laboratory team.
Conduct testing for sterility, endotoxin, and bioburden on drug products (including APIs, bulk drug products, final intermediate products, and aseptic intermediates), excipients, and in-process materials.
Support and refine a comprehensive Environmental and Utilities Monitoring program.
Maintain rigorous scientific and quality standards in all work.
Adhere to high standards of Good Documentation Practices (GDP) for Good Manufacturing Practice (GMP) testing.
Execute microbiological testing to support advanced aseptic drug product manufacturing operations.
Use paper-based and automated systems to manage QC policies, procedures, and technical reports across their full lifecycle, including authoring, reviewing, approving, and retiring documents.
Review internal documentation with precision, taking personal ownership of departmental data and outputs.
Participate effectively and accurately in Quality Events.
Support the professional growth and development of QC Microbiology Technicians in the lab.
Demonstrate a team-oriented approach, serving as both a project facilitator and active contributor on special initiatives as needed.
Set deadlines, prioritize tasks for self, team members, and support groups; review and approve colleagues' work for accuracy and procedural compliance.
Collaborate with internal departments and teams to address and resolve quality issues related to facilities and manufactured products.
Embrace constructive feedback and critiques as opportunities for personal growth and departmental improvement.