Becton Dickinson
Complaint Compliance Specialist (Specialist 3)
San Diego, CA, United States · Contract
Sponsorship not specifiedDetected 1652 days ago
ExcelAuditingFDA RegulatoryPharmacovigilanceMedical DevicesLeadershipWritingMicrosoft OfficeInternal Audit
About the role
- BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.
- We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
- For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
Responsibilities
- How we lead ourselves and our work, and 3)
- Conducts review processes designed to ensure complaints conform to regulatory requirements and company policies and procedures
- Coordinates with MMS complaint handling sites to ensure consistency in complaint records and implements solutions and process efficiencies wherever possible
- Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting
- Partners with other quality professionals to address complaint related issues identified throughout the organization
Nice to have
- Accountable for individual results and impact on teams.
- Shares experience and lessons learned with others to improve processes and procedures
- Acts as a technical specialist within complaint handling and adverse event reporting to mentor or train new associates to complaint handling, as required
- Reports status of assignments to his/her supervisor on a routine basis, and follows through to complete assignments through corrections of complaint records, and completion of CAPAs or audit actions
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Desire for the repetitive auditing and reviewing of samples of complaint records sharing ownership of corrective actions with complaint handling teams
- Experience and willingness to work within BD's TrackWise Complaint Handling and CAPA systems
- Excellent writing skills, summarization skills, and knowledgeable of Quality's good documentation practices for compliant record corrections
Visa & Work Authorization
- 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 o
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This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.