Documentation Specialist

Teleflex • Durham, NC

13d

About The Position

Review and critique documentation for new, revised, custom, and foreign products for complete official documentation records required to manufacture medical products.

Requirements

• High School Diploma or equivalent required. Bachelor’s degree preferred.
• 2+ years relevant experience. A combination of education and experience will be considered.
• Experience in regulated industry highly preferred.
• Experience with PLM (eg: Agile), ERP (eg: SAP, MDG), VERACITI (Kallk), and/or UDI (eg: Lansa) systems a plus.
• Intermediate knowledge of Microsoft Suite, specifically Word and Excel.
• Solid organizational skills and attention to detail.
• Proven ability to learn and retain working knowledge of new systems and processes.
• Proven consistent performance with accuracy.
• Effective communication skills, both verbal and written.
• Proven team player and customer service oriented.
• Demonstrated sense of urgency.
• Solid and consistent ability to work in a fast-paced dynamic environment.
• Strong adaptation skills to changing priorities.
• Ability to multi-task and effectively work with competing priorities with solid accuracy.

Responsibilities

• Serve as Change Analyst and/or Artwork Data Manager and/or Data Steward within the PLM, VERACITI, ERP/MDG, and UDI database systems - Agile, SAP/MDG, DSD (Lansa), and VERACITI (Kallik).
• In coordination with the Engineering team, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP/MDG, and UDI database systems - Agile, SAP/MDG, DSD.
• Manage Pilot/Prototype ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, MCOs, ADCs, DMR review, SAP/Pre-Checks (MM Forms/Lansa Input Forms), SAP review, IPN and GTIN management, DSD registrations/publications.
• Review DMR-related documents and attachment files submitted for creation or changes. Standardize format, proofread for errors/clarity, and verify configuration.
• Submit documents for approval signatures, coordinate corrections and changes by approvers, and issue documentation package(s). Update appropriate personnel on open projects as required.
• Assist and communicate with Engineering, Marketing, and Regulatory in the preparation of new or revised product documentation packages. Assist in formalizing documentation, as required.
• Generate product labeling in VERACITI. Perform proofreading of product labeling in coordination with the labeling team, to ensure adherence to internal labeling procedures, accuracy, completeness, and formatting.
• Import and maintain current, accurate files for figures, graphics, and scanned images required for product labeling.
• Follow regulatory requirements, internal procedures, and the most recent and best practice guidance available in the areas of Design Control, DMR, change management, and inspection.
• Process electronic DHF documents in the PLM database. Review documents for formatting, clarity, and adherence to GDP.
• Provide other department support as required by manager.
• Adhere to and ensure the compliance of Teleflex' Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED