Documentation Specialist

Document Specialist

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

The Documentation Specialist is responsible for managing and maintaining company documentation and change control, issuance of tracking numbers, and assisting with training administration.  This role ensures all documents comply with internal procedures and regulatory requirements.

Main Responsibilities

• Maintain controlled spreadsheets, master lists of documents and up to date files for the following Quality Systems: Change Order (ECO), Suppliers (Reports, Lists, SCARs), Quality Operating Procedures (QOP's), Batch Records, Drawings, (DWs) Quality Work Instructions (QWI's), Investigations and Corrective Action and Preventive Action (CAPA), Audits, Training, Design History File (DHF), External documents, and Complaint Handling.
• Coordinate and support training administration for employees and ensure the appropriate documentation is completed and filed. Research and contact subject matter experts to resolve any training questions.
• Processing of change controls and monitoring of periodic reviews.
• Support and maintain the Learning Management System to ensure data integrity, report generation, and data analysis to comply with company and regulatory standards.
• Maintain and audit training documents and files to ensure compliance with company policy and regulatory guidelines.
• Prepare, issue, scan, and file quality documents such as Standard Operating Procedures (SOPs) Qualification and validation protocols, batch records, labels, logbooks, and training records.
• Support tracking and trending of KPIs. Record data, track errors and departmental metrics. Prepare reports for site management on open deviations/CAPA status, open change controls, training status, and site quality metrics, as required.
• Maintain quality, regulations and compliance information as part of a GMP library and the back-up archive for company.
• Provide necessary support for client audits and site regulatory inspections.
• Assist Quality Management with system improvement activities and Internal Audits
• Manage the document life cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
• Perform audits of records for content and adherence to standards.
• Preparing documents for off-site storage.
• Performs other related duties as assigned.

Skills and Qualification

• College degree with at least 1-2 years of experience in a GMP-regulated environment.
• Knowledge of FDA QSR requirements and ISO 13485, as they relate to document control is a must.
• Must have good verbal and written communication skills and be able to work in a team environment.
• Document specialists must be detail-oriented and able to work with a high volume of documents in a fast-paced environment. They have to be highly organized and process oriented. They must have excellent oral and written communications skills to interact with all levels of an organization. They must have excellent listening skills, and be able to handle multiple requests while detailing document activity. The incumbent interacts with operations and engineering departments to collaborate on processes, procedures and documentation.
• Microsoft Office experience is a must

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization