Principal QA Specialist
Memphis, TN, US, 38118 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, we’ll help you build a career that you can feel passionate about.
Job Summary
This role serves as a senior Quality Assurance Subject Matter Expert (SME) supporting the GMP cell therapy manufacturing operations. This roles plays a strategic part in ensuring compliance across the quality system, providing technical leadership for complex investigations, regulatory readiness, and cross-functional quality decisions. This position is hands-on expert who can partner across departments while maintaining a strong compliance posture in a fast-paced evolving environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs full investigations of major events with potential product quality impact for complex products to identify the root cause, impact assessment, and CAPA to assess quality requirements for compliance with regulatory requirements
• Provides Quality Assurance (QA) assessment and approval for Change Controls, supports Quality Management activities with strategic initiatives and metrics, assembles Change Control Assessments, supports Deviation Risk Assessments and reviews and approves CAPAs
• Lead or contribute significantly to top regulatory inspections preparation, hosting and response efforts. Offer guidance on Good Manufacturing Practices (GMP) compliance strategies related to cell therapy processes, raw materials, and supply chain controls.
• Collaborate cross-functionally with Manufacturing, MSAT, Supply Chain, Quality Control and Regulatory to drive right-first-time execution and continuous improvement.
• Support QA oversight of aseptic operations and cleanroom behavior, serving as a QA lead during critical operations in compliance with cGMP and SOP regulations, as needed.
• Actively lead, coach and mentor other quality professionals and other individuals from all parts of CRL with varying levels of experience to deepen business and quality acumen
• Perform preventative tasks and provide documentation to avoid deviations
• Perform periodic assessments of Quality related data and documentation to maintain a state of audit readiness
• Influences as a resource and departmental SME for Quality related questions or topics including Regulatory, Corporate, and Site-specific requirements
• Delegate tasks within the Quality Operations function and drive progress to completion during execution to the required standard and ensure on-time completion of Quality deliverables
• Ensure strategic alignment with deliverables by leading execution efforts across key internal stakeholders
• Strong attention to detail
• Triage real-time quality impact of events in conjunction with employees in support of deviation management
• Conduct internal audits of facility, equipment, manufacturing areas, and warehouse and provide written reports summarizing findings
• Recommend improvements in QA through procedures or processes as they relate to inspection readiness and compliance
• Perform trending and analysis of deviations and works with responsible area owners to identify opportunities for improvement
• Build trust and influence within different departments of the operation by being a top Quality advisor to Operators
Job Qualifications
- Bachelors degree in a life science or related field preferred
- Minimum of 8 years GMP related experience in biopharmaceutical and/or pharmaceutical or related industry or a combination of 6 years of education and related work experience required
- Understanding of US and EU cGMP guidelines and requirements
- Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to functional area leadership
- Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
- Ability to understand operational documents for GMP compliance, accuracy, and completeness
- Ability to work by influencing a matrix management system and to gain the cooperation of others
- Ability to multi-task effectively
- Excellent written and verbal communication skills
- Ability to prioritize daily activities in order to meet internal 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) and Quality Management Systems such as Trackwise, SmartSolve, and Maximo
The pay range for this position is $95,000 - $136,000. 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 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, or 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: Memphis
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