Quality Assurance Supervisor (41175)

Young Innovations; Brantford; Vor Ort; CAD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Health, dental, and vision coverage

Group RRSP

Parental leave

Statutory holidays

Paid time off

Disability insurance

Employee assistance program

Zusammenfassung

Germiphene Corporation, a Young Innovations company, is seeking a Quality Assurance Supervisor at the Brantford site. You will lead investigations, CAPAs, and KPI trending within Drug GMP and ISO 13485/MDSAP frameworks, while mentoring QA staff and contributing to continuous improvement.

You will report to the Quality Manager and collaborate with QA, QC, Operations, and R&D to ensure audit readiness and robust QMS performance across production and QA activities.

Qualifikationen

• University degree in a science discipline.
• Minimum five years of quality assurance experience in pharmaceutical or medical device manufacturing.

Aufgaben

• Lead investigations of deviations, OOS results, non-conformances, and CAPA closures.
• Lead Annual Product Quality Reviews and regulatory summary reporting.
• Author and revise SOPs, forms, and QA documentation.
• Supervise QA staff and provide coaching and development.

Kenntnisse

Root cause analysis

Regulatory writing

Auditing

Team leadership

Data analysis

Ausbildung

Bachelor's degree in science

Tools

Electronic QMS systems

MS Office

Analytical instrumentation (HPLC/GC)

Jobbeschreibung

Job Details: Job Location: Brantford, ON N3S 0H4, 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 Health™

We 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 Corporation, a Young Innovations company and Health Canada‑licensed manufacturer of dental pharmaceutical and natural health products, is hiring a Quality Assurance Supervisor. Reporting to the Quality Manager, this is a hands‑on leadership role with accountability for the day‑to‑day health of the QMS, including investigations, annual product reviews, KPI trending, and SOP authorship across both Drug GMP and ISO 13485 / MDSAP frameworks. The Quality Supervisor leads a team within the Quality Assurance Department and is accountable for the supervision and development of assigned staff to drive timely, defensible closure of deviations, CAPAs, and out‑of‑specification events. They will be expected to strengthen the QMS through KPI trending, SOP authorship, and continuous improvement work that reduces repeat failures and supports audit readiness.

You’ll like this role if:

• You like structured problem‑solving and the satisfaction of getting to a real root cause.
• You write clearly and plainly, and you can defend what you wrote in front of an auditor.
• You are comfortable juggling several investigations, CAPAs, and deliverables at once and pushing each forward without losing the thread.
• You enjoy working with people across Operations, QC, RA, and R&D, and you can mentor junior staff on RCA and quality documentation.
• You are comfortable leading a small team, and you see developing your direct reports as part of how quality improves.
• You want to see the impact of your work – in this role, your investigations and trending directly shape how the site improves.

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.
• Real ownership from day one. You will lead investigations end to end, author SOPs that go into production, and see your trending work shape decisions across the site.

Who you’ll work with:

• You will report to the Quality Manager and work closely with QA, QC, Operations, Regulatory Affairs, and R&D colleagues at the Brantford site, as well as Young Innovations corporate Quality counterparts at our sister facilities.

What You’ll Do:

Investigations and CAPA

• Lead investigations of deviations, out‑of‑specification (OOS) results, non‑conformances, product complaints, and rework events.
• Apply structured root cause analysis tools (Fishbone, 5 Whys, FMEA) and author clear, defensible investigation reports.
• Drive all investigation CAPAs to closure, including verification of effectiveness.
• Identify systemic issues across investigations and elevation to the Quality Manager as appropriate.

Annual Reviews and Summary Reports

• Lead Annual Product Quality Reviews (APQR) for assigned products, including data compilation, trending, and conclusions on process state of control.
• Coordinate Annual Summary Reports (ASR) with Regulatory Affairs including literature searches and adverse‑event data review.
• Support pharmacovigilance data collection and prepare Issue‑Related Summary Reports (IRSR) at the request of Health Canada or the VP Quality.

SOPs, KPIs, Audits, and Continuous Improvement

• Author, revise, and approve SOPs and forms within delegated authority.
• Track and report on quality KPIs informed by complaint trends, and deviation/OOS history; identify improvement opportunities and partner with Operations and QC to eliminate recurring failures.
• Lead internal audit response and act as subject‑matter expert during external audits (Health Canada, MDSAP, ISO 13485, customer) under the direction of the Quality Manager.
• Mentor and provide technical guidance to QA Associates and shop‑floor QA staff on investigations, RCA, and documentation.

Staff Supervision

• Supervise assigned quality department direct reports, including day‑to‑day workload assignment and prioritization.
• Conduct performance reviews and provide ongoing coaching and feedback to support individual development.
• Identify training needs and coordinate or deliver GMP and role‑specific training for direct reports.
• Escalate performance concerns to the Quality Manager as appropriate.

Qualifications: What You’ll Bring:

• University degree in a science discipline (chemistry, biology, pharmaceutical sciences, microbiology, or related).
• Minimum five years of progressively responsible quality assurance experience in pharmaceutical or medical device manufacturing.
• Demonstrated experience leading deviation, OOS, complaint, and CAPA investigations and authoring investigation reports.
• Working knowledge of Health Canada Drug GMP (GUI‑0001) and ISO 13485 / MDSAP requirements; experience supporting external regulatory inspections is preferred.
• Strong technical and regulatory writing, able to draft defensible SOPs, investigations, and audit responses in clear, plain language.
• Sound analytical and statistical literacy for KPI trending and stability data interpretation.
• Sound judgment in assessing risk, scope of impact, and escalation needs; comfortable juggling concurrent priorities under time pressure.
• Ability to provide constructive technical guidance to junior QA staff.
• Prior experience managing or supervising quality department staff, including performance management, workload assignment, and development of direct reports.

Technical Skills

• Hands‑on experience with structured root cause analysis tools (Fishbone, 5 Whys, FMEA) and risk‑based decision‑making.
• Proficiency with electronic QMS systems, including audit‑trail reviews.
• Proficiency with MS Office (Word, Excel, PowerPoint); comfort with data analysis and trending.
• Experience with HPLC, GC and related analytical method understanding is an asset (not required).

Travel Requirements

Minimal. Occasional travel to supplier sites or sister Young Innovations facilities may be required.

Work Environment

Manufacturing/Distribution EnvironmentThis position operates in a pharmaceutical manufacturing environment. The role routinely involves working in or around manufacturing and laboratory areas, including machinery, equipment, and moving mechanical parts. The facility may be subject to varying temperatures, noise, and airborne particles such as dust or chemical fumes, depending on the area. PPE and gowning are required when entering production or QC areas. The role may require periods of standing, sitting, or walking throughout the workday. Occasional bending, lifting, or carrying items up to 23 kg may be necessary.

Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly required to sit. Hearing abilities required for this environment include being able to clearly hear and respond to audible alarms, production equipment, forklifts, and other machinery to maintain a safe work environment. Individuals must be able to distinguish and understand verbal communication including instructions, safety warnings, and team discussions, sometimes in an environment with moderate to high background noise.

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.