Microbiology Supervisor in at Prolong Pharmaceuticals LLC

Position Summary

The Microbiology Supervisor is responsible for overseeing day-to-day microbiology laboratory operations, supervising laboratory personnel, and ensuring microbiological testing and environmental monitoring activities are performed in compliance with cGMP requirements. This position supports product release, quality systems, laboratory investigations, and continuous improvement initiatives while maintaining a compliant and efficient laboratory operation.

Essential Duties & Responsibilities

• Coordinates microbiological testing, release of product, and testing for validation protocols.
• Performs organism identification.
• Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
• May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
• Reviews and approves environmental monitoring data, laboratory equipment, and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
• Trains other Microbiologists on Department methods, processes, and procedures.
• Works with other departments to accomplish Company goals or projects.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Position Requirements and Qualifications:

• Bachelor's degree in Biology, Microbiology, or related scientific discipline. 5+ years of microbiology laboratory experience in a cGMP environment. 2+ years of supervisory or leadership experience. Certification from professional organizations such as ASQ and ISPE is desired but not required.
• Working knowledge of cGMP regulations (21 CFR Parts 210, 211, and applicable regulations).
• Working knowledge of Quality Systems including Deviations, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ).
• Ability to read and interpret safety rules, operating instructions, technical procedures, and regulatory requirements.
• Ability to prepare reports, documentation, and business correspondence.
• Effective verbal communication and presentation skills. · Ability to interpret and apply written, verbal, schematic, and procedural instructions.
• Strong organizational, analytical, and problem-solving skills.
• Proficiency with Microsoft Office and applicable laboratory systems.
• Strong organizational skills with the ability to prioritize multiple assignments and meet deadlines.

Reporting and Work Environment

• Typing, desk work, and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.
• General work environment and physical demands as required to successfully perform the essential functions of this job.
• Ability to work flexible hours as needed.
• Ability to work under pressure and meet deadlines.

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Prolong Pharmaceuticals, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Prolong Pharmaceuticals, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.