The Plant Microbiologist leads the process of assuring the plant has hygienic systems, processes, and equipment in place and is responsible for development and implementation of solutions needed for hygiene issues. The role has oversight for the Research& Innovation (R&I) Challenge Testing program at Rantoul Plant and to support R&I New Product Development (NPD). The role is responsible for managing the microbiology laboratory, coaching and developing personnel, and performing or supervising performance of all microbiology testing. This role has responsibility for leading and supporting key Quality Assurance Capability development at the plant.
DUTIES AND RESPONSIBILITIES
Manage and oversee daily microbiology laboratory operations including supervision of Microbiologist and Micro Lab Technician(s) – ensuring compliance with SOPs, test methods, safety procedures, plant policies, good laboratory practices, and good documentation practices.
Continuous evaluation and improvement of micro laboratory SOPs, test methods, and work instruction, efficiency and cost. Ensure established safety and quality procedures are followed.
Perform microbiology testing of water, raw materials, bulks and finished goods according to product specifications, Combe test methods and official compendia, and Combe SOPs.
Interpret testing results and initiate additional testing as needed to confirm or isolate issues, using professional judgment and following established procedures.
Manages the R&I Challenge testing program. Conduct challenge testing (preservative effectiveness), report results promptly, and investigate findings.
Conduct, analyze, and report plant environmental air monitoring and perform growth promotion testing on incoming media. Development improvement actions if needed.
Lead laboratory investigations, deviations, and CAPAs
Perform or provide assistance (as necessary) into plant process investigations, consumer complaints, and CAPAs
Write and perform IQ/OQ/PQ for micro laboratory equipment
Coach and develop laboratory staff to continuously increase their skills and contribution
Keep Quality management and plant management informed of micro issues that could impact production schedules, product release or GMP compliance.
Develop and implement strategies, tactics, and action plans to improve plant hygiene.
Influence and work cross functionally to identify needed design solutions and upgrades to existing systems and equipment to better meet hygienic design criteria.
Actively participate in external regulatory inspections, internal hygiene/QA audits and suppliers/ Co-Manufacturing Plants audits.
Lead development and implementation of improved quality assurance systems and micro capability in the plant and across the company.
Other duties and projects as periodically assigned
EXPERIENCE AND KNOWLEDGE
Bachelor’s Degree in Microbiology or related field required, advanced degree preferred
At least 5 years’ experience in OTC and/or medical device products QC microbiology (food, drug, ans/or cosmetic) in a manufacturing environment
At least 5 years working in a cGMP environment and leading hygienic improvements
Experienced in Microbiology challenge testing programs (Both for the US and Europe), reporting, and investigations.
Direct experience interacting with regulatory inspectors such as FDA and ISO, preferred
Internal auditing experience, preferred
Experience with preservatives and preservation methods is a plus.
Formulation experience in R&D environment is a plus
Mechanical aptitude is a plus
Additional Salary Information: Salary will commensurate with experience.