Silgan Global Product Steward in Grandview, Missouri
This is a multi-faceted position which coordinates with every department at most North American and Global facilities to cover highly technical / complicated challenges related to colorants (leading the current Color and Regulatory Compliance Administrator). The majority of time is spent on Product Stewardship/Supply Chain responsibilities. Also, this employee acts as Lead to Product Stewards globally and works to mitigate risk. Proficient in all activities of Color and Regulatory Administrator to ensure support as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Other duties may be assigned. Note: Must follow all work rules and policies.
Mitigate Risk. Understand current manufacturing infrastructure. Balance operations infrastructure capabilities with customer requests and requirements (GMPs and raw materials vs healthcare/FDA regulations). Hold, review, interpret, and document legal requirements for customers based on their specifications.
Manage Drug Master Files including issuing Letters of Authorization, issuing and ensuring FDA compliance, submitting annual report, acting as FDA Agent for Germany (importing medical devices and registering them annually.) Also includes CTD vs CTE formatting requirement. Position also supports implementation of new DMFs globally and required FDA/EU medical testing, as devices are launched.
Oversee plastic regulations. Employee must have ability to issue regulatory position statements, understand regulations and how they apply to our products, and maintain relevant data from all suppliers. Also must complete customer questionnaires regarding regulatory compliance. Also, must establish and lead lab testing of raw materials and finished articles.
Responsible for raw material qualification, pre-production, including regulatory compliance of end-use application and educating suppliers on regulations.
Work with customers and suppliers, explaining and educating them regarding regulations. Obtain and provide them required regulatory information.
Ensure production ability within customer requirements before production begins. Provide guidance to legal and global procurement before material changes/Force Majeure. Work with sales force to resolve customer questions and represent technical perspective.
Continuously improve and manage Global Materials Database, Globally Approved Materials Documents, New Material Qualifications and research/development projects. Assist in leading Force Majeure and Alternate Material Qualifications.
Manage Color Laboratory and Product Steward Specialist
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s Degree (BS) required
Minimum of 5 years in similar regulatory environment
Understanding of FDA regulations
Regulatory compliance experience preferred
Ability to communicate with variety of internal and external partners, including legal division
Strong working knowledge of resin and plastics beneficial
Requisition ID: 9830