BD (Becton, Dickinson and Company) Quality Assurance Specialist in San Diego, California
Job Description Summary
The Quality Assurance Specialist is responsible for the day to day administration/managing of all quality documents related to the release of Certificate of Medical Necessity Finished Goods inventory for customer orders. These activities may include but not limited to review and approval of hard copy and electronic documents in SAP serial number Manifest, SAP Certificate of Medical Necessity, Ship Hold Documents, and Packing/Shipping Documents. The Quality Assurance Specialist works with relevant departments to ensure successful processing of product related to Certificate of Medical Necessity orders.
Review and approve required Quality Systems documents relating to the release of Certificate of Medical Necessity inventory for customer order.
Ensure certificate of medical necessity documentation is error free.
Generate and maintain accurate records for Quality Systems documents using SAP and other company databases to ensure records are clear and compliant to company QMS.
Perform document processing, distribution and filing of controlled copies using manual and electronic systems per established procedures.
Works under general direction from Management.
Independently determines and develops approach to solutions.
Make decisions and provide recommendations for business project and activities.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.
Generate charts and presentation material to report Quality Metrics for the assigned work area as required by Management.
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.
Good organizational skills and attention to detail.
Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
Consistent application of Quality system standards to assigned Quality system area.
Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements.
Experience understanding and applying Quality Systems regulations and standards, including GDP
Individual must work well with others, in a positive, collaborative work environment.
Excellent problem solving and analytical skills.
MS Word, Excel, and PowerPoint required.
PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS
Typically requires a minimum of a Bachelor’s Degree
ASQ certification preferred
Experience in SAP
ISO 13485 and/or FDA CFR Part 820 and Part 11
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
Primary Work LocationUSA CA - San Diego - Otay Mesa
Additional LocationsUSA CA - San Diego TC Bldg C&D
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.