Compliance Specialist Ii

7 months ago

Guelph, Canada Johnson & Johnson Full time

Description

Kenvue is currently recruiting for a:
Compliance Specialist II

This position reports into Compliance Lead and is based at Guelph, ON, Canada.

**Who We Are**

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

**Role reports to**:Compliance Lead

**Location**:Guelph, ON, Canada.

**Travel %**: less than 10%

**What You Will Do**

***

The Compliance Specialist II provides leadership and administrative support to MAKE Q&C at the Guelph Site, supporting supplier governance, site audit readiness, internal and external audits, document control and updates, and controlled substance compliance. The Compliance Specialist II is responsible for the coordination of non-conformance investigations at the site, working closely with primary investigators and external suppliers through the end-to-end process and helping to facilitate root cause problem solving and develop corrective actions. Additionally, the Compliance Specialist II will perform metric analysis related to non-conformance trending, compliance gaps/risks, and cycle time to communicate to the management team.

The Compliance Specialist II will be responsible for acquiring their A/RPIC designation under which they will work to ensure that precursor chemicals are manufactured, stored, controlled, disposed of, and appropriately reported as outlined in the Precursor Control Regulations (PCR), the guidelines of the Health Canada Office of Controlled Substances (OCS) and internal Kenvue procedures.

Major Duties & Responsibilities
- Management of the Investigation Program, specifically focused on Supplier Quality (coordination, metric analysis, RCA, CAPA ownership)
- Ownership of the Guelph site MENSEN program and Supplier Governance meetings
- Continuous improvement through the investigation program; resolution of roadblocks
- ARPIC: support Site RPIC to ensure site compliance, own the precursor destruction process, lead security access assessments for site personnel, and continuous improvement of precursor program.
- Document Updates and Control
- Support to Internal and External Audits
- Support to Supplier Quality Agreements

Other Duties (as required)
- Support Change Control activities
- Author investigation reports
- Author Quality Risk Management
- Participate in site audit readiness activities
- Experience balancing multiple complex investigations simultaneously, while prioritizing and adapting to business needs with a sense of urgency
- Demonstrated ability to lead a cross functional team through complex problems
- Excellent communication/writing skills for writing clear, concise and understandable instruction
- Ability to generate, collect, and analyze data from complex systems.
- Strong computer skill and business system knowledge (SAP, MES, MAXIMO, etc.)
- Sound knowledge of GMP regulations
- Experience with Analytical and Microbiology Laboratory equipment and methods is an asset
- Ability to work with limited supervision and function effectively in a team environment
- Good interpersonal and collaboration skills
- Proven ability to organize and prioritize workload with moving timelines
- Proven problem solving capability
- Excellent decision-making abilities
- Knowledge of Process Excellence/Lean an asset.

Working Conditions:

- Regular exposure to hazardous chemicals, noise, odors, dirt/dust, fumes, temperature extremes, vibration and other undesirable workplace conditions should be noted here
- Nature of work requires that the employee be in an isolated or crowded area. Travel for business purposes should be noted if frequency is more than once per month.
- Packaging Lines - hearing protection required Supporting investigations by visiting Manufacturing floor, PPE required

**Qualifications**:
**What we are looking for**

Required Qualifications
- Required Minimum Education: Bachelor’s degree in science / engineering or related field
- Required Years of Related Experience: Minimum 4 years relevant experience in a Quality, R&D or Production environment in the pharmaceutical, food or water industries.
- Must meet Health Canada requirements for ARPIC designation.
- Detail-oriented and comfortable working with a high level of detail to ensure that all regulations and requirements are fulfilled.
- Ability to take own

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