Haemonetics Document Control Specialist in Mexico
Title: Document Control Specialist
Job Number: 161111699
Provides required control of regulated documentation to meet good manufacturing practices (cGMP), good laboratory practices (GLP), good clinical practices (GCP) and good documentation practices (GDP), procedure manuals, quality control manuals, manufacturing orders, and change authorizations in accordance with company policy and government regulations. Implements and maintains an Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented.
• Document Control subject matter expert and represents the worldwide documentation control department as required.
• Supports Agile users to assure timely, accurate and efficient document generation and revision.
• Maintains and administers Document and Change Control procedures in compliance with cGMP and ISO 13485 document control regulations and guidelines.
• Executing to key performance indicator metrics for documentation control including preparation and distribution of reports as needed.
• Provides support documentation to meet customer and FDA requirements as well as documentation preparation required for internal, customer, and 3rd party audits..
• Ensures cGMP documents are maintained in a secure and organized manner and ensures documentation is retrievable and accurate.
• Manages retention of applicable corporate, regional, site monthly meeting materials, minutes or files as required.
• Monitors and tracks the review, approval, and distribution of documents to ensure timely completion to meet established time lines.
• Resolves complex Document Control issues.
• Responsible for managing on site storage of documentation and serve as interface for off-site provider as required.
• Reviews change control packages for correctness and completeness.
• Manages secure database directory and documentation processing functions and determines appropriate access for users.
• Provides Document Control guidance and support, such as training and troubleshooting, to the user community as required.
• Provides overall guidance/leadership for regulatory documentation services and practices.
• Provides documentation assistance on non-design / R&D Projects.
• Provide 2D/3D CAD support to departments as required.
• Provide support to acquisition and integration activities.
Required Associate's Degree or equivalent training and experience
Preferred Bachelor's Degree B.A
Required 5 years Documentation control experience in a regulated environment
Preferred Other Experience in the medical device industry
Required Other Experience with Electronic documentation management
Licenses and Certifications:
Preferred Agile (PLM) software experience
Required 2D/3D software experience
Required Microsoft Office (Word, Excel, Powerpoint) experience
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Documentation control experience in a regulated environment
Preferred Experience in the medical device industry
Required Experience with Electronic documentation management