Quality Operations Supervisor

Charles River • Full-time • Rockville, MD, US • $83,380 - $105,200 / year • 6d ago

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

This leadership role is responsible for a team of Quality Operations Specialists, which will require providing oversight of quality documentation and operations in adherence to cGMPs and SOP regulations. QOps Supervisors will represent Quality at cross-functional meetings, providing Quality input and decision making in Quality events and deviations. They will provide training to groups and departments when needed.

Essential Duties And Responsibilities

Assume supervisory responsibility for a team of Quality Operations (QOps) Specialists, including scheduling, work assignment, and productivity monitoring
Coordinate review of manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.
Support Internal Management System by engagement in Work Center Team activities
Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion
Create, review and approve documents in electronic document management systems
Serve as QOps representative for client project teams as assigned by management
Coordinate performance of key QOps functions by team members, including line clearances, general manufacturing support, product shipment, raw material receipt and release, etc.
Participate in departmental and cross-functional continuous improvement efforts
Train and mentor assigned QOps Specialists and Leads
Consistently set a high standard for quality of work
Promote a safety mindset through daily actions and communication with team members
Manage risk and escalate issues to QOps management in a timely manner
Communicate professionally, effectively, and efficiently with all clients, internal and external
Demonstrate flexibility when confronted with high stress/emergency situations, shifting
Perform all other duties as necessary

Job Qualifications

Bachelors degree in a life science or related field preferred
Minimum of 5 year GMP related experience in biopharmaceutical/pharmaceutical or related industry or a combination of 5 years of education and related work experience required
Demonstrated leadership capability
Experience with GMP regulatory requirements
Ability to multi-task effectively
Excellent written and verbal communication skills
Ability to prioritize daily activities in order to meet client needs on time of established time lines in a fast-paced environment
Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point)

Compensation Data

The pay range for this position is $83,380 to $105,200. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, 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 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 (including sexual orientation, gender identity, and expression), 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.

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