What are the responsibilities and job description for the Document Control Specialist position at ALOIS Solutions?
📌 Position: Coordinator I – Quality Document Systems Management
📍 Location: Zelienople, PA 16063
🏭 Industry: Medical Devices / Healthcare Manufacturing
Position Description
The Quality Document Systems Management role supports the development, maintenance, and control of quality documentation and related systems. This position is ideal for candidates with limited experience who are looking to build foundational skills in quality documentation within a regulated manufacturing environment.
The role involves handling routine, well-defined tasks using established procedures, with work reviewed by senior team members. Training and guidance will be provided.
Key Responsibilities
- Labeling, filing, and maintaining Device History Records (DHRs)
- Creating and filing DHR Service Records when documentation is missing
- Packing and archiving records that have met retention requirements
- Filing Quality and Environmental records as required
- Updating Tables of Contents, Binder Revisions, and Controlled Location Charts
- Updating binders following Change Request (CR) releases
- Issuing copies of archived or draft procedures to Production or Service teams
- Managing on-site and off-site DHR requests
- Maintaining and organizing Service files and cabinets
- Rearranging and labeling cabinets to ensure proper storage
- Issuing new document and procedure numbers for the site
- Creating and updating supplier profiles in MFG Pro
- Sending Certificates of Conformance (CoCs), testing data, and scanned DHRs upon request
- Completing requisition forms for office and documentation supplies
Qualifications
- Vocational qualification or equivalent experience
- Basic understanding of documentation control or administrative processes
- Strong organizational and attention-to-detail skills
- Ability to follow established procedures in a regulated environment
- Basic computer proficiency; experience with ERP or documentation systems is a plus
📩 Interested candidates are encouraged to apply or reach out for more details.