Quality Document Coordinator

Young-Innovations; Illinois; On-site; USD 30,307 - 35,817; Full time

Benefits offered by this job

Health, dental, and vision coverage

Group RRSP

Parental leave

Paid time off

Short- and long-term disability

Job summary

Germiphene, a Young Innovations company, is seeking a detail-driven Quality Assurance Document Coordinator to maintain our controlled document system, manage QT9 document control, and track deliverables across investigations and change controls in a regulated dental pharmaceutical manufacturing environment.

You will administer the QT9 training program, support audits, and generate metrics for management reviews, reporting to the Quality Assurance Supervisor.

Qualifications

• 3+ years in a regulated GMP/ISO 13485 manufacturing environment.
• Experience with electronic QMS platforms (QT9 preferred).
• Advanced proficiency in Microsoft Office.
• Strong written and oral communication.
• Excellent organizational skills with attention to timelines.

Responsibilities

• Document Control: maintain Master Document List, archives, and approvals.
• Deliverable & Timeline Tracking: monitor investigations and change controls.
• Training Administration: manage QT9 training program and roll-out of new docs.
• Audit Readiness & Reporting: assist audits and compile QMS metrics.
• Coordinate across Quality team to ensure timely closure of tasks.

Skills

QT9

Microsoft Office

Document control

Tracking & scheduling

Audits preparation

Regulatory compliance

Communication skills

Project management

Education

High School Diploma

Tools

QT9

MasterControl

TrackWise

ETQ

Job description

Company Summary:At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral HealthWe embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you're looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.Position Overview: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.Purpose of the role: 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.You'll like this role if:You're the person who notices when something's about to be overdue before anyone asks.You like structure, systems, and keeping things organized more than you like ambiguity.You want a role with real ownership of a system, without managing people.You're comfortable juggling multiple trackers, deadlines, and stakeholders at once.Why You'll Love Working Here:Medium sized company, not too big, not too small, just enough to get things done and see your impact.Did we say benefits? Health, dental, and vision coverage; group RRSP; parental leave; statutory holidays; paid time off; short- and long-term disability insurance; employee assistance program; and more.You'll own a visible, essential piece of our Quality system, your work is what keeps audits and inspections running smoothly.Who you'll work with:Reports to the Quality Assurance Supervisor. Works closely across the whole Quality team, the Quality Assurance Supervisor, Quality Assurance Associates, Quality Control Supervisor, Microbiology Supervisor, and Quality Engineering Specialist, as the shared document-control and deliverable-tracking point of contact for all of them.What You'll Do:Document ControlMaintain 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.Deliverable & Timeline TrackingTrack 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.Training AdministrationAdminister 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.Audit Readiness & ReportingAssist 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).What You'll Bring:High School Diploma required; post-secondary education in a related field an assetMinimum of 3 years of experience in a regulated GMP/ISO 13485 manufacturing environmentDirect 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 themStrong analytical and rational thinking, with the discipline to validate completeness and timelines without stepping into technical review of document contentAbility to prioritize competing tasks and deadlines under pressureSuperior organizational skills, able to manage multiple trackers, deadlines, and stakeholders simultaneouslyHigh attention to detail and accuracyProject Management experience an assetAutonomous and self-directed, comfortable owning a system with minimal oversightComfortable escalating issues rather than resolving them personally when something falls outside this role's scopeCompensation Range: $22.00/hr.–$26.00/hr.The pay range reflects the minimum and maximum target for the position at the time of posting. Within the range, the compensation will be determined based on education/training, skill set, experience, and other organizational needs.Work EnvironmentOffice EnvironmentThis position is based in an office environment and is primarily sedentary in nature. It requires regular use of standard office equipment, including computers, phones, photocopiers, scanners, and filing cabinets. Employees may be required to sit, stand, or walk for extended periods, and occasional bending, lifting, or carrying items up to 40 pounds may be necessary. Some exposure to the manufacturing environment should be expected.This position is available due to an existing vacancy.In compliance with AODA legislation, if you require accommodation during any part of the recruitment process, please advise Human Resources.