Quality Specialist Iii

5 months ago

Guelph, Canada Kenvue Full time

**Quality Specialist III -Internal Auditor**-2307010200W

Description

**Kenvue** is currently recruiting for a Quality Specialist III-Internal Auditor

**Kenvue,** based in Guelph, Ontario, Canada, is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

The Quality Specialist III will be accountable to provide guidance on compliance and Good Manufacturing Practice (GMP) that pertains to internal and external audits, where applicable, to meet Kenvue standards and regulatory expectations. This individual will have experience in sound and timely decision making by using statistical and problem solving tools as well as experience in quality auditing.

This individual will confirm compliance to cGMPs and identify the most significant audit findings and prioritize for remediation action. The Quality Specialist III will lead, sell, and implement improvement opportunities and problem solutions for audit observations at the Guelph manufacturing site.

The Quality Specialist III will support investigations pertaining to observations made during audits and ensure that deviations are addressed in a timely manner and that corrective actions meet company and regulatory expectations. The Quality Specialist III will provide timely decisions and consultations in alignment with cGMP, Kenvue and regulatory guidelines.

**Key Responsibilities**:

- Communicate to Quality Management the observations made during audits. Maintain metrics and support management reviews and other presentations.
- Maintain knowledge of regulatory environments, cGMPs, Health Canada/FDA policies and current industry trends and prepare and present written and verbal reports to upper management.
- Provide QA support and coverage to operations and perform other duties as assigned.
- Engage in Supplier Quality events and take ownership for investigations and Root Cause problem solving as required
- Coordinate and/or perform audits to determine compliance with regulations and standards including audit preparation, audit notification, pre-audit meeting, audit execution, Report and corrective action preparation and audit close out meeting.
- Prepare annual Service Provider audit schedule and ensure schedule is executed according to schedule.
- Prepare annual Internal audit schedule and ensure schedule is executed according to schedule.
- Monitor, track and follow up on corrective actions associated with audit observations.
- Keep QA Manager, Director and Compliance Lead abreast of audit progress and current audit findings
- Engage in cross functional organization to develop policies and processes to comply with new cGMP, USP, and CFR requirements/guidance at the site.
- Provides Change Control information for annual Drug Product Reports
- Maintains the GMP evidence database
- Performs other duties, as assigned.

Qualifications

**Qualifications**:

- A minimum of a University/Bachelors Degree or higher is **required.**
- A minimum of four (4) years related experience with Quality Assurance in Pharmaceutical, Medical Device, OTC Drug and/or Cosmetic production environment is **required**
- Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision is **required**
- Prior experience preparing and presenting written and verbal reports to upper management and business unit heads pertaining to audit findings is **required**
- Ability to work effectively on cross functional teams is **required**
- Strong influencing skills is **preferred**

**What’s in it for you**
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
- Learning & Development Opportunities
- Employee Resource Groups

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Primary Location NA-CA-Ontario-Guelph

Job Function Quality (Generalist)

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