Report

Supervisor QC Microbiology (Memphis, TN, US, 38118)

Salary

$76k - $82k

Min Experience

3 years

Location

Memphis, Tennessee, United States

JobType

full-time

About the job

Info This job is sourced from a job board

Overview

About the role

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

Supervisor QC Microbiology requires working knowledge of Environmental Monitoring of Good Manufacturing Practices (GMP) cleanrooms including how to appropriately and effectively complete investigations of excursions. Familiarity with compendial microbiological testing methods for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.), is essential.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•   Leads all activities associated with daily operations of the QC Micro Department
•   Oversee the performance of QC Analyst providing support and guidance by coaching areas of growth and development and recognizing and rewarding successes
•   Reviews and maintains documentation and records for accuracy and compliance
•   Prepare for and actively participate in internal and external audits, investigations, and reporting
•   Provide direction and technical expertise to Micro team
•   Utilize common problem-solving tools and methodologies in processes and procedures for root cause analysis and resolution
•   Seek to understand and operate within the department budget, cost and profitability restraints, and ensure that materials meet regulatory requirements
•   Ensure timely response and closure of customer complaints
•   Conducts and leads meetings and communications effectively
•   Prepares and facilitates reporting, as requested by QC Micro Leadership Team
•   Manages KPI performance, goals, and objectives
•   Issues and traces necessary deviations, change controls, CAPAs, related to QC Micro Department
•   Review and approve QC Micro data for accuracy and compliance to applicable SOPs and Test Methods
•   Supports and coordinates special projects and other assignments related to QC Micro Department
•   Must be able to report onsite, work flexible hours, split shifts, during weekends and holidays as the operations of the business requires
•   Perform other duties as assigned

Job Qualifications

•   Bachelor's degree in biology or relevant scientific discipline
•   3-4 years of relevant Microbiology experience preferred or equivalent combination of education and experience
•   Ability to supervise and manage the schedule of Analysts
•   Ability and desire to take initiative on department-wide improvement projects and drive to completion.
•   Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.
•   Ability to process large amounts of paperwork in a timely and efficient manner.
•   Previous experience supervising/scheduling staff for a 24/7 operation desired.
•   Experience with microbiology laboratory design requirements, setting up/equipping, and inventorying.
•   Experience in culturing microbes and use of various classical microbiology and biochemical techniques such as gram stain, streak plate, spread plates etc.
•   Experience in data/statistical analysis, data trending, reporting results and presenting data in group and client meetings.
•   Excellent writing skills. Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc. Ability to write deviations, Environmental Monitoring investigations, OOS reports, CAPAs.
•   Understanding of cGMP/GLP regulations as well as excellent GDP (documentation skills).
•   Familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of aseptic processes, biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
•   Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
•   Ability to multitask, problem solve and troubleshoot as necessary.

Compensation Data

The pay range for this position is $36.54- $39.43. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Charles River’s CDMO Services

With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

About the company

Charles River Laboratories International, Inc. provides research tools and support services for drug discovery and development. The Company offers animal research models in research and development for new drugs, devices, and therapies. Charles River Laboratories International serves pharmaceutical and biotechnology companies, hospitals, and academic institutions worldwide.

Skills

Environmental Monitoring

PCR

Streak Plate

GMP