Compliance Specialist II - Jobs in Guelph, ON

Job Description

Johnson & Johnson Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Compliance Specialist II located at Guelph, Ontario.Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.The Compliance Specialist II provides leadership and administrative support to MAKE Q&C at the Guelph Site, supporting 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 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 J&J procedures.Major Duties & Responsibilities

• Management of the Investigation Program (coordination, metric analysis, RCA, CAPA ownership)
• Continuous improvement through the investigation program; resolution of roadblocks
• ARPIC: support Site RPIC to ensure site compliance, lead 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

QualificationsRequired Qualifications

• Degree in Science / Engineering or related field
• Must meet Health Canada requirements for ARPIC designation
• Minimum 4 years relevant experience in a Quality, R&D or Production environment in the pharmaceutical, food or water industries.

Required Knowledge, Skills and Abilities:

• Detail-oriented and comfortable working with a high level of detail to ensure that all regulations and requirements are fulfilled
• Ability to take ownership for and work independently with accuracy and with a high-capacity output
• 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 and problem-solving capability
• Excellent decision-making abilities
• Knowledge of Process Excellence/Lean an asset.

Preferred Qualifications:

• People Management Experience
• Pharmaceutical, Manufacturing, Food related industry experience
• Statistical analysis (Minitab, R, SPSS, etc.)

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.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 LocationCanada-Ontario-Guelph-890 Woodlawn Road WestOrganizationJohnson & Johnson Inc. (7695)Job FunctionQualityRequisition ID2206046334WQuick Apply

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