Job Information
BD (Becton, Dickinson and Company) Quality Systems Specialist I, Document Control in Franklin Lakes, New Jersey
Job Description SummaryProvides support for Document Management for BD Global level Quality, Regulatory, & Medical Affairs documents
Job Description
Provides support for Document Management for BD Global level Quality, Regulatory, & Medical Affairs documents.
Assists in the Change Control Board (CCB) process for Global level documents including:
Collecting CCB feedback and working with document authors on final drafts ensuring appropriate feedback resolution
Managing a CCB document tracker within Teams
Assisting in the scheduling of CCB presenters
Creating meeting minutes and providing follow-up on action items
Coordinating the routing of final documents into SAP ECC 6
Reviews and makes necessary corrections to Global documents for formatting requirements, typographical errors, and completeness.
Reviews Engineering Change Request Forms (ECRs) for accuracy and completeness and directs the change requestor on required corrections.
Identifies and implements opportunities for continual improvement.
Collaborates with all business units, manufacturing sites, distribution centers, and/or regions on any requests/ suggestions for QS element improvement opportunity.
Continually assess the components of the Quality System, associated processes and electronic solutions via two way feedback from the Businesses, Plants, Regions, and networks to provide continual improvement.
Identifies, communicates, resolves, and escalates any quality system related risk that may potentially derail/delay objectives or adversely affect the Quality System.
Assists in the maintenance of various Sharepoint sites/Portals used for communication & data gathering for quality system areas such as Corporate Documents & ISO QS certificates
Minimum Qualifications:
BS in Science/Engineering or relevant discipline desired
Two or more years of Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices or diagnostics.
Experience in electronic document management systems. Prefer SAP ECC6.0 DMS and/ or MasterControl
Experience authoring and/or reviewing quality documents or records in a regulated environment
Ability to travel up to 10%
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, or any other protected status.
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Primary Work LocationUSA NJ - Franklin Lakes
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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.