Supervisor, Micro Quality
Date: Nov 8, 2024
Location: US-FL-Tampa, Florida, US
Company: Bausch + Lomb
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Supervisor, Micro Quality
Objectives/Purpose of the Job:
Oversee the Environmental Monitoring (EM) program for the facility in agreement with all regulatory requirements. Supervise EM personnel performing routine and non-routine environmental monitoring in support of sterile manufacturing operations.
Key Activities/Responsibilities:
- Management and scheduling of day-to-day EM activities/personnel to meet Manufacturing needs.
- Coordinate with Manufacturing and other departments to solve/prevent production related problems.
- Ensure EM personnel are properly trained/qualified to perform assigned tasks.
- Provide coaching and conduct performance evaluations for EM personnel to support career development.
- Ensure site and department objectives are communicated and met.
- Draft and/or approve validation protocols/reports (ex. EMPQs)
- Draft and/or approve EM procedures for enhancement, clarity, corrections, etc.
- Oversee inventory of EM equipment and supplies.
- Oversee non-routine monitoring in conjunction with investigations, projects, and/or validation activities.
- Oversee visual inspection of media fill units for turbidity/microbial contamination.
- Ensure EM excursions are properly investigated and effective CAPAs are implemented to prevent recurrence.
- Coordinate microbiology data release activities including compilation, review, data entry, etc.
- Oversee the trending of EM data.
- Oversee the collection of critical utility samples (WFI/Pure Air).
- Represent the EM function during audits.
- Implement continuous improvement initiatives within the department to reduce costs, increase compliance, reduce timelines, increase efficiencies, etc.
- All other duties as assigned.
Qualifications/Training:
- Bachelor's degree in Microbiology, Biology, or equivalent Life Science required.
- 5+ years of relevant work experience required, preferably in Microbiology and/or Environmental Monitoring in an Aseptic Manufacturing Facility.
- 2+ years of leadership experience preferred.
Physical Requirements / Working Conditions:
- Ability to lift and/or carry 25 lbs.
- Ability to achieve 20/20 correctable vision.
- Ability to maintain proper personal hygiene.
- Ability to wear laboratory PPE/attire.
- Ability to gown aseptically and work in a controlled environment for extended periods of time (no makeup, jewelry, fingernail polish, etc.)
Required Knowledge, Skills, & Abilities:
- Ability to communicate effectively with direct reports, peers, and management.
- Ability to work in a fast-paced environment.
- Ability to work full-time, onsite, including overtime and weekends if necessary to meet department/site objectives.
- Strong leadership, time management, planning, and organizational skills.
- Thorough knowledge of Aseptic Manufacturing processes and applicable regulations (e.g. FDA, USP, ISO, etc.).
- Excellent oral and written communication skills.
- Advanced knowledge of microbiological testing/environmental monitoring techniques
Eligibility for Internal Applicants:
- Must meet the minimum required qualifications for this position.
- Must have been in current position for NLT 12 months.
- No written warnings in the past 6 months.
- No final warnings in the past 12 months.
- Not currently on a performance improvement plan.
This position may be available in the following location: Tampa, FL
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch+Lomb's Job Offer Fraud Statement.
Our Benefit Programs: https://www.bausch.com/careers/benefits/
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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