Essential Duties and Responsibilities:The Petrifilm QC Lab Manager is the strategic and administrative leader of the QC Laboratory, accountable for quality compliance, departmental performance, and final product quality release. Essential duties include:
- Directly manage the QC Lab Supervisor, guiding their focus on daily lab flow, training, and troubleshooting. Responsible for staff performance reviews, compensation reviews, and hiring decisions for the department.
- Hold final accountability for the release or rejection of Petrifilm products, ensuring all quality standards and regulatory requirements are met before material is released.
- Serve as the primary point person for the QC Lab function during all regulatory agency inspections and internal/external quality audits. Oversee internal inspection readiness and drive the on-time closure of all audit commitments.
- Lead the development and optimization of all quality systems and processes specific to the QC Lab. Author and manage all Standard Test Procedures (STPs), Standard Operating Procedures (SOPs), and Risk Assessments for the laboratory.
- Manage the departmental budget for consumables, capital equipment, and labor. Responsible for compiling, analyzing, and reporting key laboratory metrics, including On-Time Release performance, OOS investigation closure rate, and managing quality alignment along the manufacturing line.
- Lead the investigation and closure process for all Out-of-Specification (OOS) results and assist the Quality Engineer in all internal and external quality investigations related to the QC Lab, identifying root causes and developing effective corrective and preventative actions.
- Define and establish departmental Objectives and Key Results (OKRs) that align the QC Lab's goals with the overall organizational and Quality department strategy.
Skills and Competencies:- Leading Others: Delegates tasks appropriately to the Supervisor to enhance team effectiveness. Leverages team strengths to drive performance and testing efficiency.
- Organizational Strategy: Is the expert in the QC function and uses understanding of the organization to help drive performance.
- Decision Making and Problem Solving: Possesses innovative problem-solving skills, particularly in complex quality investigations (OOS, audit responses). Ensures the team and Supervisor have the information and tools necessary to make compliant decisions, while retaining final accountability.
- Driving Performance: Creates accountability for Objectives and Key Results (OKRs). Utilizes time and resources effectively to control the lab budget and meet critical metrics like On-Time Release.
- Communication: Clearly conveys information and ideas through a variety of media, varying the message based on the audience (e.g., technicians, Director, auditors). Fosters collaboration across departments.
- Cultural Fit: Demonstrates and lives Neogen's Pillars of Trust (Openness, Honesty, Credibility, Respect, and Service) in all actions and behaviors.
Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:- Ph.D. in Microbiology or a closely related science field AND 0-1 year of related experience.
- OR Master's Degree in Microbiology or a closely related science field AND 3-4 years of related experience in a QC/QA environment AND a minimum of 3 years of direct managerial experience.
- OR Bachelor's Degree in Microbiology or a closely related science field AND a minimum of 6-7 years of related experience in a QC/QA environment AND a minimum of 3 years of direct managerial experience.
- OR Associate's Degree in a science-related field AND 9-11 years of related experience in a QC/QA environment AND a minimum of 3 years of direct managerial experience.
- OR High School Diploma/GED AND a minimum of 15-16 years of progressive lab experience AND a minimum of 7 years of related experience in QC/QA environment AND a minimum of 3 years of direct managerial experience.
- Proven experience acting as a designated trainer or technical resource is required.
- Advanced knowledge of GLP, ISO, and relevant regulatory standards is required.
Language Skills:- Advanced ability to read and interpret complex regulatory, procedural, and scientific documents in English.
- Exceptional ability to write formal reports, SOPs, and correspondence, and to speak effectively as the lab's representative to regulatory auditors, executive leadership, and technical teams.
Mathematical Skills:- Ability to perform routine, college-level mathematical operations, including statistical functions relevant to microbiological data analysis (e.g., CFU calculations, growth curves), trend analysis, risk assessment, and reporting quality metrics.
Computer Skills:- Solid knowledge of computers and operating systems, including software used for data acquisition and analysis in a microbiology lab.
- Ability to effectively communicate electronically.
- Required knowledge and experience with Microsoft Office Suite (Word, Excel, PowerPoint) is essential for authoring documents, managing data, and presenting reports.
Physical Demands:- While performing the duties of this job, the employee is regularly required to see, talk, or hear.
- Frequently required to stand, walk, and sit, especially when working in a microbiology lab.
- Occasionally required to use hands to handle or feel, reach with hands and arms, climb or balance, and stoop, kneel, crouch, or crawl, particularly when setting up or maintaining microbiological equipment.
- Must occasionally lift and/or move up to 25 pounds, such as media bottles or equipment.
- Specific vision abilities required include high visual acuity and color vision, especially for accurate reading of microbiological results and differentiation of microbial growth.
- Employee must pass a standardized color deficiency test with a score of > 80%.
Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- This is primarily an office-based role, with frequent interaction with the BSL-2 laboratory environment.
- Requires adherence to strict aseptic techniques and the consistent use of personal protective equipment (PPE), including lab coats, gloves, and eye protection, especially in the microbiology lab.
- The employee is occasionally exposed to fumes/airborne particles/odors/microbiological hazards.
- The noise level in the work environment is usually moderate to quiet.
