Microbiology Supervisor I

Description Overview

To ensure the Quality and Compliance of raw materials and products by overseeing daily Microbiology laboratory activities including testing and personnel for the support of Perrigo operations and manufacturing needs.

Scope of the Role

The Microbiology lab Supervisor is responsible for leading a team of Microbiologists that provides testing of topical, nasal spray and suppository pharmaceutical products. This role ensures compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal quality systems, and approved procedures. The Microbiology lab Supervisor serves as a key quality Subject Matter Expert for microbial risk assessments in project teams for Manufacturing, Packaging, Engineering, and Validation.

Schedule: First shift, Monday through Friday. Occasional weekend on-call support may be required.

Experience Required

· Bachelor’s Degree in Biology, Microbiology or related discipline, with three or more years experience in a GMP laboratory environment and one or more years of previous supervisory experience. Consideration can be given to candidates without previous supervisory experience who meet all other qualifications and possess considerable laboratory knowledge in a pharmaceutical environment.

· Responsible for implementing and monitoring cGMP requirements for all data generated by the QC laboratory, including data integrity and controls.

· Responsible for day-to -day activities of micro lab including scheduling of work, data review and release, and safety requirements

· Responsible as registered supervisor for microbiology lab in NYS board of pharmacy permit and maintains renewal

· Supervise, coach, evaluate, and oversee training of Microbiologists responsible for the testing of raw material, products, water and environmental monitoring of manufacturing and packaging operations.

· Ensure all lab activates comply with cGMP requirements, FDA regulations, approved procedures, and internal SOPs.

· Provide Microbiology support to operations by addressing quality concerns, conducting risk assessments, and escalating issues when appropriate.

· Perform micro risk assessment 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 microbiology lab procedures as needed.

· Author investigations involving OOS or atypical results, environmental monitoring excursions, and other quality events in which microbiological risk is present.

· Design and implement appropriate CAPAs

· Monitor compliance trends and identify opportunities for continuous improvement.

· Act as microbiology SME during inspections, customer audits, and internal audits while maintaining inspection readiness and implementing remediation activities.

· Track and trend lab performance and safety metrics and implement changes when necessary to maintain customer service