Supervisor QC Microbiology - Memphis, United States - Charles River Laboratories

Description

Supervisor QC Microbiology

Req ID #:

Location:

Memphis, TN, US, 38118

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, well 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 Biologics Testing Solutions**

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

**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 clients 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 peoples 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 supported the development of 86% of the drugs approved by the FDA in 2021.

**Equal Employment Opportunity**

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

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 [email protected] . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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