Published: May 14, 2018
- 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.
- On-going 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, environment, raw materials, bulks and finished goods according to product specifications, company test methods and official compendia, and company 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. Develop and lead 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 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
- Candidate must be willing to relocate to: Rantoul, Illinois.
- Bachelor’s Degree in Microbiology or related field required, advanced degree preferred
- 5-10 years’ experience in OTC and/or medical device products QC microbiology (food, drug, and/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, 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
- Formulation experience in R&D environment is a plus
- 3-5 years’ experience effectively managing people and teams
- Mechanical aptitude is a plus
- Excellent organizational and verbal/written communication skills
- Excellent verbal and written English Language capability
- Demonstrated strong collaboration skills – ability to work cross functionally to meet business needs and implement improvements.
- Demonstrated Influential Leadership skills
- Demonstrate strong computer skills in Excel, Word, Outlook
- Working knowledge of consumer product microbiology techniques according to FDA, CTFA, and other authoritative sources
- Ability to identify microorganisms using traditional and automated technology is desirable.
- Must be able to work weekends, as necessary
- Must be able to travel up to 15% of the time
- Demonstrated skills coaching and developing others.
- Supervision of personnel - Microbiologist and Micro Lab Technician(s)