Document Control Specialist

Overview:

The Document Control Specialist is a junior-level quality role. The primary function of this role is to keep Make Wellness's Quality Management System (QMS) in good order — specifically, ensuring that all controlled documents are current, approved, accessible, and properly maintained throughout their lifecycle.

This is a coordination and administration role with a quality foundation. The successful candidate will work closely with the QA Head and subject matter experts across the business to gather, route for approval, publish, and archive QMS documents. They will also support the broader QA team on document-related tasks arising from regulatory inspections, audits, product and market expansion, and operational changes.

This role does not require deep regulatory expertise at entry — that knowledge will develop on the job. What it does require is a methodical approach to detail, comfort working within defined processes, and the initiative to keep documentation cycles moving without constant prompting.

Key Responsibilities:

Document Lifestyle Management

• Maintain the master document register, ensuring all controlled documents are listed with current revision status, effective dates, owner, and review due dates
• Track documents through the full lifecycle: drafting, review, approval routing, publication, periodic review, revision, and archival
• Coordinate approvals from document owners and approvers, following up proactively to keep review cycles on schedule
• Publish approved documents to the controlled document repository and retire superseded versions in accordance with SOP-DC-001
• Maintain a clear separation between controlled (current) documents and archived versions, with no live access to superseded documents
• Ensure all documents carry the correct version number, effective date, review date, and approval signatures before publication

Document Intake

• Receive new document drafts from the QA Head or subject matter experts and prepare them for review and approval routing
• Check new documents against the document control requirements in SOP-DC-001 prior to routing — formatting, numbering, required fields, approval block completeness
• Coordinate with document authors to resolve formatting or completeness issues before the formal review cycle begins
• Open change control records for new documents and revisions as required by SOP-DC-001

Periodic Review

• Maintain a rolling review calendar for all controlled documents and issue advance notice to document owners when reviews are due
• Follow up with document owners to ensure reviews are completed, outcomes are documented, and revised documents are re-approved and republished on schedule
• Escalate overdue reviews to the QA Head and flag any document whose review is significantly past due

Records & Audit Readiness

• Maintain QMS records in accordance with retention schedules, ensuring records are retrievable, legible, and protected from unauthorized alteration
• Support the QA Head in preparing document packs for internal audits, external audits, and regulatory inspections
• Retrieve requested documents and records on short notice during audit or inspection events
• Identify and flag gaps in the document register or records filing system and work with the QA Head to resolve them

Training Records

• Maintain training records for QMS-related training, ensuring records are filed promptly following training events and are accessible for audit
• Issue notifications to affected personnel when document revisions trigger retraining requirements
• Follow up with training coordinators or the QA Head to confirm retraining completion is recorded

Continuous Improvement

• Identify inefficiencies or recurring issues in document control workflows and bring them to the QA Head's attention
• Support the QA Head in developing or revising document control procedures, templates, and forms as the QMS evolves
• Participate in Management Review meetings where document control performance is a standing agenda item

Required Qualifications:

• 3 years of experience in at least one of the following: document control, quality assurance or quality systems, process development or improvement, regulatory affairs, research and development, manufacturing, or another related field. A background in dietary supplements, food, or cosmetics is ideal; experience in pharmaceuticals, medical devices, or other regulated industries is also relevant
• Demonstrated experience maintaining a document register, tracking system, or equivalent structured records system
• Strong organizational skills with a track record of managing multiple concurrent tasks and deadlines without dropping details
• High level of accuracy and attention to detail — this role involves checking other people's work as well as maintaining your own
• Comfort working within defined processes and procedures, and the discipline to follow them consistently
• Clear written communication skills — this role involves routine correspondence with document owners, approvers, and the QA Head
• Proficiency with standard productivity software (Word, Excel, email) and comfort learning new systems

Preferred Qualifications:

• Background in dietary supplements, food, or cosmetics — candidates with direct experience in one of these categories are strongly preferred over other regulated industries
• Familiarity with cGMP requirements for dietary supplements (21 CFR Part 111) — working knowledge of what the regulations require from a documentation and quality systems perspective, even if not previously in a compliance role
• Familiarity with GMP requirements for cosmetics (21 CFR Parts 700–740 or equivalent) — a plus for candidates coming from a personal care or cosmetics background
• Experience with a formal document management system (DMS) or eQMS
• Exposure to FDA or Health Canada regulatory frameworks, even in a supporting or administrative capacity
• Experience supporting internal or external audits, including document retrieval and preparation

In the first 90 days, the successful candidate will have:

• Gained a working understanding of the QMS structure, document hierarchy, and the requirements of the Quality Manual and framing SOP’s
• Taken ownership of the document register and established a clear picture of the current status of all controlled documents
• Identified any documents with overdue periodic reviews and established a plan with the QA Head to address them
• Set up a review calendar and begun issuing advance notice to document owners

At six months, the successful candidate will be independently managing the document control lifecycle with minimal direction, supporting audit readiness activities, and contributing ideas for improving document control workflows.