US, York, SC Document Control Specialist (2022-108)
We are currently looking for a Document Control Specialist for our ESAS site in York, SC.
The main function of this position is to maintain and review required documentation for the smooth and continuous operation of the Quality Management System, ongoing production activities, and to meet regulatory requirements as deemed necessary, focusing on safety, quality, and productivity. This position is also responsible for actively participating in ISO internal audits and providing day to day support to production. Incumbent is expected to participate in plant safety activities and ensure compliance with quality and regulatory requirements.
PRIMARY RESPONSIBILITIES INCLUDE
- Assist in the review process of all manufacturing production records and Quality testing inspections.
- Assist in reviewing incoming production records to ensure documents are complete, scanning/saving documents to an electronic file, and saving information in the site’s electronic data file management system.
- Assist in the review of lot Certificates of Analysis and product labels as needed.
- Assist in the release and review of finished product and raw material documentation as needed.
- Assist in the filing of documentation to maintain product traceability.
- Manage/Oversee all activities involving Document Control including updating procedures as requested, managing document approvals, and posting approved copies on electronic management system.
- Maintaining the documentation for incoming raw materials and Finished Goods.
- Assist in data compilation for Quality System Reports including reporting of various site metrics (i.e. FTRPR, CCR).
- Coordinate preparation of internal audit documentation for audit team.
- Serve as back up for performing a pre-shipment audit for the all the material shipped to the customer(s).
- HS diploma plus at least 4 years of manufacturing administrative or a minimum of an Associate’s degree plus related experience
- 2-5 years minimum administrative experience, preferably document control experience in a regulated environment
- Basic knowledge of document control desired
- Basic knowledge in chemistry terminology is helpful
- Computer Literate, experience with MS Office Suite and systems such as SharePoint, Adobe, DocuSign, DocuWare
- Familiarity with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) is a plus
- Demonstrated oral and written skills with an ability to communicate and work effectively with others in various levels of the organization
Elkem will conduct a post-offer background check to confirm the information provided by candidates during the recruitment process. Additionally, a post-offer physical, including a substance screening, is required. Relevant candidates will be informed of this if it applies.
We are an Equal Opportunity Employer – M/F/Veteran/Disabled and if you are an individual with a disability, who requires an accommodation, please contact us.
- Region: North America
- Division: Silicones
- Job type: Quality
- Working hours: Full Time
- Working days:
- Application deadline: 31.03.2023
- Location: York, SC