Quality Systems Specialist II, Industrial Affairs
Job ID R-368767 Date posted 07/07/2020 Job Description Summary
The Industrial Affairs Quality Systems Specialist II provides developed skills and technical services across the worldwide business unit, of moderate scope and complexity. 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 scope and complexity.
The associate, under general 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. Will support working with 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.
Prepares and maintains BD origin specifications (e.g., animal, plant, GMO, etc.) for ingredients and OEM products acquired from outside suppliers.
Publishes BD origin metrics for Animal/Non-animal Origin material and supplier management.
Maintains existing procedures at the Quality Systems level and below.
Trains others, inside and outside of Industrial Affairs. May assign work to others.
Investigates, analyzes and develops solutions to a variety of problems of moderate scope and complexity, while using regulations, government guidance documents, and standards, as well as BD policies and procedures, for guidance.
Works under general supervision, with internal BD associates, as well as directly with customers and suppliers.
May contribute to the maintenance of USDA and CDC Import/Transport Permits, and USDA certificates related to BD product export.
May manage EDQM TSE Certificates of Suitability.
May manage AOAC-RI Certification for identified products.
May manage Design History Files for applicable BDDS manufactured products.
May respond to industrial customer requests with information and documents that meet the customer's quality / regulatory needs.
May support on-site customer audits.
May be expected to make presentations.
Represents Industrial Affairs on project teams relative to any of the above responsibilities.
Education and Experience:
Bachelor’s Degree in science or other relevant discipline required.
Minimum of 2 years or a combination of equivalent education and experience in quality systems and/or animal origin and applicable regulations.
Knowledge and Skills:
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 multi-functional teams, and independently obtain results as required with minimal supervision.
Ability to identify, analyze, develop and present solutions for problems of moderate 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.).
#LI-TECHPrimary Work Location
USA MD - BaltimoreAdditional Locations
US BD 1st Shift 8am-430pm (United States of America)