Quality Document Control Specialist
BD · Tempe, AZ · 2 mo ago
On-siteAdministrativeFull-time
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it takes the imagination and passion of all of us to look at the impossible and find transformative solutions.
This is a Fixed-Term Contract position with an anticipated end date of December 28, 2028.
Responsibilities
- Manage the day-to-day administration of change requests, including:
- Creating change requests and supporting documentation within the Electronic Document Management System (EDMS)
- Reviewing and verifying change request documentation for accuracy and completeness
- Creating, editing, and maintaining controlled documents
- Managing the full lifecycle of change requests from initiation through closure
- Tracking and reporting the status of change requests, workload, and key metrics to supervisors and project teams
- Utilize various software applications to support daily work activities
- Collaborate with project teams and document owners to drive changes to completion
- Maintain a strong compliance-focused approach to regulatory requirements and quality standards
- Participate in team and project meetings
- Identify and recommend process improvements to enhance the effectiveness and efficiency of change management activities
- Support departmental projects and related quality system processes
- Perform other duties and special projects as assigned, including:
- Assisting with investigations
- Supporting regulatory audits and inspections
Requirements
- High School Diploma or GED required
- Associate's or Bachelor's degree preferred
- Minimum of 1 year of experience in a documentation-related role, preferably within an FDA-regulated or similarly regulated environment
- 1 to 3 years of relevant professional experience
Qualifications
- Strong written, verbal, and reading proficiency in English
- Exceptional attention to detail and accuracy
- Proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint
- Strong organizational and administrative skills with the ability to prioritize competing responsibilities
- Ability to manage multiple tasks simultaneously in a fast-paced environment
- Ability to work independently and collaboratively within cross-functional teams
- Flexibility to adjust work schedules and work overtime when needed
- Professional demeanor with a positive, team-oriented attitude
Skills
- Preferred Qualifications:
- Basic understanding of quality and regulatory requirements
- Familiarity with Quality Management System (QMS) documentation and records
- Experience in quality systems, manufacturing, laboratory operations, or product development environments
- Experience using Electronic Document Management Systems (EDMS) such as MasterControl, Teamcenter, PEGA, or similar platforms
Benefits
- Eligible for BD benefits, including medical, dental, health, and 401(k), subject to the eligibility requirements of BD Total Rewards policies
Schedule
This position is a Fixed-Term (limited-term) assignment designed to support a specific business need, with an anticipated end date of December 28, 2028.
About the role
Employment is intended for a defined period and is expected to conclude upon completion of the assignment or fulfillment of the associated business objective.
Primary work location: USA AZ - Tempe Headquarters.