Quality Documentation Control Specialist

PROMED MOLDED PRODUCTS INC • Plymouth, MN

1d • $30 - $41 • Onsite

About The Position

The Quality Assurance Document Control Specialist is responsible for the 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. This role ensures that QMS components are accurate, current, revised, approved, accessible, and archived in a compliant manner. The Quality Documentation Control Specialist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field;
• 0-2 years of experience in a regulated industry (pharma, biotech, or medical device);
• Working knowledge of GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820);
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Nice To Haves

• Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile) even if primary system is paper-based;
• Experience with ISO 13485 quality management principles;
• Knowledge of ALCOA+ data integrity principles;
• Ability to work autonomously, effectively manage time and deliver results on time;
• Attention to detail and commitment to data integrity and accuracy in all quality records;
• Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations;
• Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously;
• Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions;
• Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements;
• Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items;
• Aptitude for learning and applying regulatory requirements and quality standards.

Responsibilities

• 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 escalate 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level