Senior QA Auditor
This position will function within the Quality Assurance Unit of Corporate Preclinical Development and Toxicology and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with Good Laboratory Practice (GLP) regulations and the BD CPDT Quality System.
This role will define, develop, implement, and monitor Quality System and program for CPDT to ensure that it adapts to support an ever-changing work environment.
The position will also manage multiple long-term projects emphasizing continuous improvement (CI) efforts with manager interaction as required by specific issues, milestones, or status changes.
Define, develop, implement, and monitor Quality System and program for CPDT to ensure that it adapts to support an ever-changing work and regulatory environment.
Responsibility for phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58 (GLP) compliance and the overall Quality System.
Active participation in the development, implementation, and maintenance of the BD CPDT Quality System including creating documents and instituting programs in overall support of continual quality improvement.
Responsibility for GLP and Quality System training including mentoring and training of other QA staff members as appropriate
Author and/or review of SOPs to support new and ongoing operations.
Accompany representatives from sponsoring organizations or government regulatory agencies during site visits and study audits, at the discretion of the Manager of QA.
Responsibility for GLP and Quality System training and mentoring and training of other QA staff members as appropriate.
Operate/ oversee operation of the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols and Standard Operating Procedures.
Manage change control system in support of document and process/system/equipment changes.
Support the animal facility for documentation and quality issues.
Assist in assurance of compliance with Federal and State regulations and maintenance of AAALAC accreditation.
Direct knowledge of GLP standards as in 21 CFR Part 58 and the overall Quality System as it applies to material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices.
Direct knowledge of the ISO 17025 laboratory certification program and ISO 10993 Biocompatibility Standards would be an added benefit, but not required.
Must have the ability to focus and execute multiple projects and programs simultaneously while maintaining attention to detail.
This position requires excellent organizational and computer skills and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory.
Must have excellent interpersonal skills and speaking and writing skills.
Requires a Bachelor’s degree in a scientific discipline.
Prior experience with 21 CFR Part 58 regulations is required.
Pharmaceutical or CRO experience would be a plus.
Minimum 6 to 8 years Quality Assurance experience.
Knowledge of standards required to maintain AAALAC accreditation and comply with all sate a federal regulations relating to animal care is highly desirable.
Have excellent interpersonal skills and speaking and writing skills.
Some travel may be required.
Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
Experience with LIMs a plus.
US-North Carolina-Research Triangle Park
First Shift / Day Job