Quality Assurance Document Coordinator (40580)

Young Innovations • , IL

15d • $22 - $28 • Onsite

About The Position

Germiphene, a Young Innovations company, is looking for a detail-driven Quality Assurance Document Coordinator to be the backbone of our controlled document system. You'll keep our QT9 quality system organized and audit-ready, managing document control, tracking Quality deliverable timelines across investigations and change controls, and running our training program in a regulated dental pharmaceutical manufacturing environment. The purpose of the role is to ensure Germiphene's controlled documents, training records, and Quality deliverable timelines are accurate, current, and inspection-ready at all times. You are the enamel that protects the Quality Management System from cracks and keeps it running on schedule. This role is for someone who notices when something's about to be overdue before anyone asks, likes structure, systems, and keeping things organized, and wants a role with real ownership of a system without managing people. You should be comfortable juggling multiple trackers, deadlines, and stakeholders at once.

Requirements

• High School Diploma required
• Minimum of 3 years of experience in a regulated GMP/ISO 13485 manufacturing environment
• Direct experience with an electronic QMS platform (QT9 ideally, or MasterControl / TrackWise / ETQ)
• Advanced proficiency in Microsoft Office (Excel, Word, Outlook)
• Excellent oral and written communication skills, including the confidence to follow up with and hold colleagues accountable across departments without direct authority over them
• Strong analytical and rational thinking, with the discipline to validate completeness and timelines without stepping into technical review of document content
• Ability to prioritize competing tasks and deadlines under pressure
• Superior organizational skills, able to manage multiple trackers, deadlines, and stakeholders simultaneously
• High attention to detail and accuracy

Nice To Haves

• Post-secondary education in a related field an asset
• Project Management experience an asset
• Autonomous and self-directed, comfortable owning a system with minimal oversight
• Comfortable escalating issues rather than resolving them personally when something falls outside this role's scope

Responsibilities

• Maintain the Master Document List, completed records, and document archives.
• Manage QT9 document control, review, and approval.
• Track and log finished product, raw material, component, and label releases.
• Assist in document revision creation.
• Track periodic document review due dates and flag documents coming due for review.
• Pull and retire obsolete document versions when a revision supersedes them.
• Verify that completed deliverables, including documents issued through change control, have been executed and closed appropriately against their requirements before records are finalized.
• Track due dates for investigations, CAPAs, OOS, NCR, Deviations, and change controls; proactively notify owners of upcoming, due, and overdue items.
• Validate completeness of CAPA, Change Control, and investigation records (required fields, attachments, signatures) and communicate timelines to owners.
• Escalate at-risk deadlines to the Quality Manager.
• Administer the QT9 training program: assignment, tracking, and follow-up on overdue training.
• Manage training roll-out for new/revised controlled documents.
• Maintain training records and generate training matrices for management review and regulatory inspection.
• Assist with document preparation and retrieval for regulatory audits and inspections (Health Canada GMP, MDSAP, internal audits, Pharmacovigilance audits).
• Verify that audit tasks have been executed and documented.
• Compile QMS metrics for Management Review (document change request aging, change control aging, training completion rates, and similar KPIs).

Benefits

• Health, dental, and vision coverage
• group RRSP
• parental leave
• statutory holidays
• paid time off
• short- and long-term disability insurance
• employee assistance program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED