Documentation Specialist

Position Summary

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

Principal Responsibilities

Responsibilities may include the following as they apply to ASK and EASK:
•    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.

Education / Experience 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. 

Specialized Skills / Other Requirements

•    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.

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