Quality Assurance Program Lead
4 days ago
We are seeking a Quality Assurance Program Lead to join our team at Charles River Laboratories in Memphis, TN. As a key member of our quality assurance group, you will be responsible for ensuring the site operates under applicable regulatory policies and corporate guidelines.
The ideal candidate will have a strong background in data integrity, quality control, and laboratory operations, with experience in developing and implementing SOPs, processes, and training programs. You will work closely with cross-functional teams to ensure consistency and continuity across all functional segments at the site.
Key Responsibilities:
- Develop and sustain collaborative partnerships across functions to implement, mature, and sustain delivery to DI principles and requirements.
- Ensure all new equipment and instrumentation is assessed and validated for its intended use and lifecycle management of data storage, review, and archival.
- Facilitate holistic data integrity reviews by partnering with cross-functional groups and stakeholders to conduct end-to-end business process assessments.
- Communicate actions, compliance gaps, and commitments to respective areas and report on the health of the DI program at monthly Quality Management Review governance meetings.
Requirements:
- Bachelor's degree in a science-related field (preferred).
- Minimum 7 years' experience in a regulated industry, or 5 years with related technical knowledge.
- Advanced knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Thorough understanding of data integrity review, 21CFR Part 11 requirements, and instrumentation compliance.
- Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Estimated Salary: $116,600 - $134,700 per year.
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