Senior Quality Systems Specialist (REMOTE)
Job Description Summary
The Quality Systems Specialist actively supports the development, implementation, and monitoring of an element or elements of the Quality Management System (QMS), including but not limited to Corrective and Preventive Action (CAPA), Internal Audits, Document Control, Training and Qualification, and Metrics and Data Analysis, and various other elements for the site / Business Unit. He / She monitors and maintains applicable procedures for that element of the QMS, and develops, implements or manages applicable instructions, as necessary or directed.
The Quality Systems Specialist provides guidance and training to associates related to Combination Product (Drug-Device) GMP and device quality system processes. The Quality Systems Specialist facilitates meetings and escalation, and supports departmental and organizational goals and processes.
This role can be be based onsite in Tempe, AZ or 100% remote from anywhere within the US (with occasional travel to Tempe required).
Essential Job Responsibilities:
- Works within assigned QMS element(s) in accordance with process and procedural requirements.
- Coordinates and conducts information and training sessions applicable to their designated QMS element for associates, as necessary.
- Oversees / Leads monitoring and maintenance of activities associated with and Quality Records generated from their designated QMS element in accordance with process and procedural requirements and reports upward and outward accordingly.
- Participates in regulatory compliance audits and inspections.
- Completes applicable job-specific training.
- Facilitates meetings and escalations.
- Leads investigations, as necessary.
- Maintain quality and regulatory expertise for Combination Product (Drug-Device) GMP and their designated QMS element.
- Assist in developing integrated implementation strategies for a variety of QMS elements.
- Demonstrate expert QMS skills and knowledge.
- Ability to bench mark industry trends for a given QMS element and apply results.
- Liaisons with Segment and Corporate on behalf of BDPI, as necessary.
- Bachelor's Degree in a related area / technical field.
- Minimum 6 years of relevant experience.
- Prior pharmaceutical or combination products (Device-Drug) industry experience.
- Advanced language proficiency in reading, writing, understanding, and communicating in English.
- Attention to detail.
- Understanding and working knowledge of regulations.
- Prior manufacturing, laboratory, or product development experience.
- Superior computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
- Intermediate software application experience with Microsoft SharePoint and Power BI.
- Superior organizational and administrative skills.
- Ability to travel 10-15%
* Remote Work is possible for this job opportunity.
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, or any other protected status.
Primary Work LocationUSA AZ - Tempe Headquarters
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