Job Description SummaryThe statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.
JOB SUMMARY: The Industrial Affairs Senior Quality Systems Specialist provides specialized skills and technical services across the worldwide business unit. The associate applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems of moderate to difficult scope and complexity. The associate updates existing or creates new technical documents such as animal origin documents or Quality System procedures which are related to overall business unit policies regarding Animal Origin control and traceability. The associate collects, interprets and analyzes data that supports products, process, training, CAPA, supplier management, vigilance and recall. The associate reviews and monitors data using complex databases and/or or enterprise systems.
Job Description DUTIES, RESPONSIBILITIES & AUTHORITIES
The associate, under minimal supervision, contributes to the management of animal origin for BDDS by maintaining the related quality systems, specifications, databases, and related customer/supplier facing certificates/reports. The associate will provide information and documents, as well as on-site audit support, to Industrial Customers to assist them in meeting their required documentation needs. The associate will support working with U.S. and ex- U.S government agencies and international BD associates to assure the required permits, certificates, and related documents concerning animal and non-animal origin are in place or provided, and thereby assure the smooth import of acquired materials, export of BDDS manufactured products around the world. Bulk of work pertains to media products.
KNOWLEDGE AND SKILLS:
- Uses judgment and interpretation, and applies science and Quality Systems principles, as well as technical knowledge, to fulfill assignments or projects of moderate to difficult scope and complexity.
- Trains, develops and assigns work to others; provides technical guidance to less experienced professional level staff.
- Originates new and maintains existing procedures at the Quality Systems level and below.
- Investigates, analyzes and develops solutions to a variety of problems of moderate to difficult scope and complexity, while using regulations, government guidance documents, and standards, as well as BD policies and procedures, for guidance.
- Manages EDQM TSE Certificates of Suitability.
- Manages Customer Quality Agreements.
- Manages Cold Chain and China GSP inquiries.
- Prepares and maintains BD origin specifications (e.g., animal, plant, GMO, etc.) for ingredients and OEM products acquired from outside suppliers.
- Contributes to BD origin metrics for Animal/Non-animal Origin material and supplier management.
- Interfaces with and responds to Industrial Customer requests with information and documents that meet the customer's quality / regulatory needs, providing the best customer experience possible.
- Hosts on-site customer audits.
- Represents Industrial Affairs on project teams and review boards relative to any of the above responsibilities.
- Trains associates, internal and external to Industrial Affairs.
- May contribute to the maintenance of USDA and CDC Import/Transport Permits, and USDA certificates related to BD product export.
- May manage AOAC-RI Certification for identified products.
- May manage Design History Files for applicable BDDS manufactured products
- Works under minimal supervision, with internal BD associates, as well as directly with customers, suppliers and governmental bodies.
- May hold a supervisory position.
- Expected to make presentations.
EDUCATION AND EXPERIENCE:
- Current knowledge of Quality Systems Regulations, ISO Quality System and Medical Device standards. Knowledge of USP/EP/JP desirable. Knowledge of Global Animal Origin Regulations desirable.
- Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
- Ability to organize work; project management experience desirable.
- Ability to work in teams, including large multifunctional teams, and independently obtain results as required with minimal supervision.
- Ability to identify, analyze, develop and present solutions for problems of moderate to difficult scope and complexity.
- Ability to collect, analyze data and present results to others orally or in writing.
- Self-motivated, organized, detail oriented, and able to multi-task.
- Ability to develop work plans and manage them to meet agreed upon goals.
- Skilled in Microsoft software; excellent Excel data extraction and analysis skills; SAP proficiency strongly preferred; ability to learn and master other software programs.
- Professional certification is an advantage (e.g. RAC, Six Sigma, etc.).
- Requires a minimum of a bachelor's degree in science, engineering or other relevant discipline.
- Min 5 years or a combination of equivalent education and experience.
Primary Work LocationUSA MD - Baltimore Additional Locations Work ShiftUS BD 1st Shift 8am-430pm (United States of America)
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.