Manager - Quality Control
Mattawan, MI, US, 49071
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
Quality Control supports the review and archival of analysis performed by Laboratory Science disciplines that may include dose formulations, large and small molecule analysis, molecular and cell-based assays, Biomarker, and flow cytometry-based lab work. Staff participate in the review of methods; equipment records and the creation of report tables. Staff are knowledgeable in the application of GxP’s and applicable SOPs, protocols and ensuring adherence to regulatory documents.
Essential Functions:
- Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
- Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong
- Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics
- Assist with providing costing estimates for components of applicable studies
- Provide short- and long-term solutions that support continuous improvement
- Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
- Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements
- Establish and review Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
- Develop and maintain contemporaneous knowledge of regulatory requirements
- Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
- Monitor performance metrics for operational area
- Function as a Principal Investigator, Individual Scientist, and/or Project Scientist as required by operational area or resourcing need
- Skillfully oversee the design, conduct, interpretation and reporting of studies
- Effectively utilize project management systems
- Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs
- Perform all other related duties as assigned
Job Qualifications
- Bachelor’s degree or equivalent with 8-10 years of relevant experience. Between 3-4 years of management experience required
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Ability to communicate verbally and in writing at all levels inside and outside the organization
- Basic familiarity with Microsoft Office Suite
- Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
- Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
- Ability to work under specific time constraints
The pay range for this position is $85-90K/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 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, national origin, veteran or disability status.
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.
Nearest Major Market: Kalamazoo
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