Commercial Quality Staff Analyst

2 weeks ago

Guelph, Ontario, Canada Kenvue Full time

Commercial Quality Staff Analyst W

Description


Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., 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.


Reporting to the Commercial Quality Manager, the CQ Staff Analyst will have responsibility for the Quality and Compliance oversight for the 3PL managed Canadian Consumer Distribution Center, Trade Customization, and Indirect Supplier Quality functions.

This position will require strong internal and external collaboration and partnering.

Key Responsibilities:

  • Maintains quality records on nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner. Coordinates change control documentation and approval process. Makes proposals and assists in the development of corrective action plans and monitors implementation. Follows up on closure of corrective and preventive actions. Provides quality support for technology transfer and improvement of existing processes. Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Has thorough understanding of process criteria and regulations and business impact of decisions and actions. Assesses current quality systems and recommends improvements to enhance quality and reduce cycle time. Prepares for and facilitates audits and inspections. Monitors trends, identifies issues, recommends, and implements appropriate actions. Assists in the development, implementation, and review of standard operating procedures for interactions with contract manufacturers.
  • Provide Quality Oversight for the Distribution Center's daily issues/inquires via regular meetings, supplier audits and Quality System reviews. Tracks and provides KPIs / metrics for Distribution Operations and Commercial Quality to facilitate the review of ongoing quality performance.
  • Executes the tactics, projects and goals and objectives across the Quality Systems and Quality Compliance, to ensure delivery against the strategies and measures related to Commercial Quality business, compliance, and culture/credo goals.
  • Ensure quality systems are well integrated into the business in critical areas for control including product receipt, storage, handling, transportation, supplier control, nonconformance management, change management, document/records management, validation, and training.
  • Complete training to support other Consumer Commercial Quality activities, as needed, such as: returns processing, recall management, DC month end processes, new product introductions and product dispositioning.
  • Interfaces and builds partnerships with source companies, Marketing companies and thirdparty suppliers. Drives consistent processes and requirements through the establishment of efficient and compliant SOPs across all Partner companies and 3PLs.
  • Gathers metrics and data needed for the Quality System Management Review regarding the compliance status and performance of the distribution center.
  • Supports regulatory inspections (both internal and external) via preparation, participation, response writing and implementing corrective actions as appropriate to ensure Quality and Compliance of the Consumer DC and TC business
  • Provides Quality input and support to the Distribution & TC Canada training process.
  • Follow all company guidelines related to Quality and Regulatory Compliance and that all resources needed to do so are available.
  • Responsible for supporting the Escalation of issues as per JNJ Standards.
  • Implements and executes the quality system to ensure adherence to Good Manufacturing/Distribution Practices.

Qualifications

Education:

Minimum Bachelor or equivalent of Science Degree in life sciences, chemistry, or related science discipline

Experience and Skills:

Required:

  • Minimum of 6 years of experience in the pharmaceutical industry within Quality Assurance or Manufacturing, with previous exposure to management and administrative responsibilities
  • Knowledge of SAP
  • Excellent interpersonal skills

Preferred:

  • GMP auditing experience
  • Knowledge Tru Specification Lifecycle Management process
  • Knowledge of Process Excellence and Project Management
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

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