Quality Assurance Supervisor

Req ID #:  101763
Location: 

Frederick, MD, US, 21701 Durham, NC, US, 27703

For 70 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

Supervise and provide support in the management of daily work flow operations of Quality Assurance (QA) staff.  Ensure staff assignments are in alignment with regulatory inspection and reporting requirements.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Oversee daily operational activities/schedules and ensure QA resources are properly assigned to manage regulatory oversight.  
•    Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.
•    Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
•    Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.  
•    Participate in client site visits and regulatory inspections.
•    Participate in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.     
•    Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles.
•    Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
•    May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
•    Assure the suitability of materials and supplies for compliance with specifications (GMP QA).
•    Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product (GMP QA).
•    As required, oversee maintenance of group training manual and training records.
•    May assist in development of departmental budget.
•    Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development.
 

Job Qualifications

QUALIFICATIONS:
•    Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
•    Experience:   Minimum 5 years experience in a Quality Assurance role or a GLP environment including 1 year supervisory experience.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/Licensure:  None.
•    Other:  Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).  Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Excellent judgment, decision-making, training/mentoring skills and verbal/written communication skills. Strong leadership, organizational skills and detail oriented. Able to prioritize workload and manage multiple tasks. 

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

 

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 supported the development of ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

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: Washington DC

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