Quality Document Control Specialist

BRIGHT RESEARCH PARTNERS INC • Minneapolis, MN

1d • $60,000 - $75,000

About The Position

Bright Research, a medical device clinical research organization based in downtown Minneapolis, is seeking a Quality Document Control Specialist to support its Quality Management System and maintain document integrity, compliance, and operational excellence. The role administers controlled-document and records-management processes throughout the document lifecycle and helps ensure quality documents and records are managed accurately and in compliance with applicable requirements. The specialist also supports electronic quality and document management systems, training records, metrics, audits, inspections, CAPA activities, and change controls.

Requirements

• At least 2 years of experience in document control, quality systems, regulatory affairs, manufacturing, or a related function in a regulated industry.
• Strong understanding of document lifecycle management, change control, records retention, and archival requirements.
• Experience working with electronic document management or quality systems and Microsoft 365 applications.
• Exceptional attention to detail and organizational skills.
• Strong written communication abilities.

Nice To Haves

• Knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and applicable quality and regulatory requirements.

Responsibilities

• Administer and maintain controlled-document and records-management processes, including document creation, review, approval, issuance, revision, distribution, retention, archival, and obsolescence.
• Maintain SOPs, work instructions, forms, and quality records through version control, metadata management, approval workflows, and audit trails.
• Guide document owners through document control processes and provide training.
• Maintain training assignments and completion records.
• Support administration and continuous improvement of eQMS and eDMS platforms and related document-management processes.
• Prepare document control, training, and quality metrics.
• Support audits, inspections, CAPA activities, and change controls.

Benefits

• Complimentary paid parking.
• Comprehensive medical, dental, and vision insurance.
• Paid parental leave.
• Short- and long-term disability benefits.
• 401(k) with company match.
• Tuition reimbursement.
• At least 12 paid company holidays.
• Access to an on-site gym.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed