Quality Documentation Control Specialist

Quality Documentation Control Specialist

Full Time Plymouth, MN, US

30+ days ago Requisition

Salary Range: $29.68 To $40.96 Hourly

Team:
Quality

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well‑being of people around the world.

Working as one to help many.

The Quality Assurance Document Control Specialist is responsible for day‑to‑day administration, maintenance, and continuous improvement of the organization’s document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment. Ensuring that QMS components are accurate, current, revised, approved, accessible and archived in a compliant manner.

The Quality Documentation Control Specialist ensures Pro Med’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Position duties and responsibilities include, but are not limited to the following:

• Administer the operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records);
• Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version;
• Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use;
• Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs);
• Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements;
• Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards;
• Oversee the creation, review, approval and distribution of controlled documents, including SOPs, policies, forms and work instructions with ALCOA principles;
• Maintains the documentation files in compliance with ISO 13485. FDA 21 CFR 820
• and 21 CFR Part 11;
• Manage electronic and physical document repositories;
• Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion;
• Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner as applicable;
• Inputs data to create and revise material and method masters in the ERP system.

• Identify and elevate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager;
• Participate in internal audits and self‑inspections as assigned; support corrective action follow‑up activities;
• Support the implementation of regulatory changes and quality system improvements as directed;
• Assist in preparing responses to audit observations or regulatory findings that involve document or records management.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability…