Microbiology Supervisor I

Perrigo•New York, NY

About The Position

The Microbiology Supervisor I oversees daily microbiology laboratory activities, testing, and personnel to ensure the quality and compliance of raw materials and products and support Perrigo operations and manufacturing needs. The role leads a team of Microbiologists testing topical, nasal spray, and suppository pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal quality systems, and approved procedures. The supervisor serves as a quality subject matter expert on microbial risk assessments for Manufacturing, Packaging, Engineering, and Validation project teams. The schedule is first shift, Monday through Friday, with occasional weekend on-call support potentially required.

Requirements

Bachelor’s degree in Biology, Microbiology, or a related discipline.
At least three years of experience in a GMP laboratory environment.
At least one year of previous supervisory experience; consideration may be given to candidates without supervisory experience who meet the other qualifications and have considerable laboratory knowledge in a pharmaceutical environment.

Responsibilities

Implement and monitor cGMP requirements for QC laboratory data, including data integrity and controls.
Manage day-to-day microbiology laboratory activities, including work scheduling, data review and release, and safety requirements.
Serve as registered supervisor for the microbiology laboratory on the New York State Board of Pharmacy permit and maintain its renewal.
Supervise, coach, evaluate, and oversee training of Microbiologists testing raw materials, products, water, and environmental monitoring samples from manufacturing and packaging operations.
Ensure laboratory activities comply with cGMP requirements, FDA regulations, approved procedures, and internal SOPs.
Support operations by addressing quality concerns, conducting risk assessments, and escalating issues when appropriate.
Perform microbial risk assessments for new raw materials and formulations to justify and assign appropriate specifications.
Author, revise, review, and approve SOPs, test methods, specifications, and other controlled documents; develop new procedures and improve existing laboratory procedures as needed.
Author investigations involving out-of-specification or atypical results, environmental monitoring excursions, and other quality events involving microbiological risk.
Design and implement appropriate CAPAs.
Monitor compliance trends and identify opportunities for continuous improvement.
Act as the microbiology subject matter expert during inspections and customer and internal audits; maintain inspection readiness and implement remediation activities.
Track and trend laboratory performance and safety metrics and implement changes as necessary to maintain customer service.