BD (Becton, Dickinson and Company) Quality Systems Specialist II in Research Triangle Park, North Carolina
Job Description SummaryThis position will function within the Quality Assurance Unit of Corporate Preclinical Development & Toxicology (CPDT) and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System.
Quality Assurance strives to live BD values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
The Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.
Primary Responsibilities and Duties:
Responsible for utilizing and developing phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58 and the overall Quality System. Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by BD CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
Operate the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols, Reports and Standard Operating Procedures.
Support the BD CPDT Training System to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
Active Participation in the development, implementation and maintenance of various aspects of the BD CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
Accompany representatives from sponsoring organizations or government regulatory agencies during site audits.
Responsible for GLP and Quality System training.
Responsible for maintenance of the Master Schedule.
Serve as backup for the BD CPDT GLP Archives for all controlled records, documents and samples.
Assist with Metrology program including maintenance of Regulatory Asset Manager System.
Assist in management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
Collaborate with managers, scientists and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency.
Maintain an environment of continuous improvement and quality aligned with BD core values and strategic objectives.
KSA Requirements (Knowledge, Skills, and Abilities):
Typically requires a minimum of a Bachelor’s Degree in a scientific discipline.
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.
Moderate level of application of Quality System Standards to assigned Quality system area.
Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements
Demonstrated ability to work successfully independently as well as part of a team.
Excellent verbal and written communication skills.
Must have the ability to focus and to execute multiple projects and programs simultaneously while maintaining attention to detail.
This position requires excellent organizational and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
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