BD (Becton, Dickinson and Company) Vivarium Documentation Specialist in Research Triangle Park, North Carolina
Job Description Summary
This position will function within the Vivarium unit of Corporate Preclinical Development and Toxicology (CPDT) and will function as a documentation specialist to nonclinical laboratory investigations of medical devices and materials in accordance with FDA, GLP regulations and the BD CPDT Quality System.
The Vivarium Documentation Specialist is accountable for ensuring compliance with documentation requirements for all Vivarium SOPs as well as other pertinent CPDT SOPs. This position will be actively involved with both vivarium users as well as the quality assurance team in an effort to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.
Review data generated by Vivarium users to ensure adherence to Vivarium SOPs and CPDT Quality System in direct support of 21 CFR Part 58.
Manage program requirements of the Metrology program including maintenance of Regulatory Asset Manager System.
Support the BD CPDT Training System to ensure vivarium employee training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
Perform quality data reviews as needed for studies related to corporate preclinical development.
Actively participate in the development, implementation and maintenance of various aspects of the BD CPDT Quality System including reviewing documents (SOPs, Procedures, Methods, and Protocols) in overall support of continual quality improvement in the vivarium.
Maintain an environment of continuous improvement and quality aligned with BD core values and strategic objectives.
At least 3 years work experience in quality-related field preferred, preferably including work in a GLP or GMP environment.
Experience with laboratory animals is preferred
Primary Work LocationUSA NC - Research Triangle Park
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status