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QA Pharma Compliance Specialist - Madison, WI

 

DuPont

 

INTRODUCTION

DuPont Nutrition & Biosciences business is a world leader delivering innovative and sustainable solutions across food, health, pharma and biotech industries encompassing approximately 70 manufacturing locations, 20 Application Centers and 10 Global R&D Centers. With annual revenues exceeding 6B, we are a global, diverse and inclusive winning team of more than 10,000 employees based in more than 50 countries. Benefitting from our diversity in nationalities, gender, educational and personal backgrounds, we are joint in our ambition to bring solutions to the world which enable a more sustainable and healthy world!

Learn more about our Featured solutions here: https://www.dupont.com/about/our-businesses.html

For your awareness, DuPont has announced their intent to merge Nutrition and Biosciences (N&B) business, which you are joining, with International Flavors & Fragrances (IFF) company with an anticipated closing date in the first quarter of 2021. At closing, you will become an employee of the newly merged company.

THE ROLE & RESPONSIBILITIES

This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP’s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by DuPont with all internal, customer and regulatory requirements. This position reports directly to the QA Manufacturing Lead - Pharma Project Manager for the Madison site and is directly responsible for the implementation and maintenance of the Management Systems at the Madison site.

Your key responsibilities:

  • Provide leadership, coordination, insight and individual contribution in obtaining and maintaining Pharmaceutical API compliance.
  • Act as the primary backup to the QA Pharma Compliance Lead.
  • Contribute to the review and assessment of Deviations, Management of Change, Corrective Actions, and Non-Conformances.
  • Participate in the review and approval of validation documentation.
  • Participate in customer, certification, and regulatory audits and following up on corrective actions, as needed.
  • Contribute to monitoring and trending of process performance for APR (Annual Product Review) and plant continuous improvement initiatives.
  • Assist with the creation and communication of new and changing procedures to the site under the established documentation control procedures and in compliance with certification standards and company guidelines.
  • Perform internal audits for the maintenance and continuous improvement of the management system and compliance to regulatory requirements.
  • Review and release of batch records (both production and QC) in compliance with various internal and external requirements.
  • Review and assess Out-Of-Tolerance (OOT) reports in regards to product quality.
  • Organize and perform quality training (i.e. GMP, GDP) for plant personnel.
  • Coordinate systems between Corporate Q&FS and the site
  • Ensure adherence to DuPont’s Quality and Environmental Policies and Procedures.
  • Comply with all company policies, including maintaining a drug free work place.
  • Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality.

Qualifications

Your qualification profile:

  • Bachelor’s degree in Microbiology, Biology, Food Science, or related field or a minimum of 3 years of experience in Quality Assurance/Quality Control, cGMP’s, Food Safety or Regulatory Compliance.
  • Experience working in a GMP environment (i.e. ICH Q7, medical devices or dietary supplements).
  • Must possess effective communication, interpersonal, team-building skills at various levels with other departments. Must be comfortable speaking in front of large groups.
  • Must possess strong organizational and time-management skills and the ability to work independently.
  • Must be willing to participate and contribute to team-based problem-solving of manufacturing quality events and/or issues.
  • Experience with the following is desired but not required:
    • Regulatory and/or customer audits
    • Experience with CAPA (Corrective & Preventative Actions) systems
    • Internal auditing
    • Training presentations relevant to Management Systems;

WORKING CONDITIONS

This position operates in both the office and plant environments.

Must adhere to plant GMPs and wear Personal Protective Equipment (PPE) as appropriate in accordance with plant policy.

At DuPont, we have an unbridled commitment to deliver essential innovations that enrich people’s lives, enable sustainable development and foster human potential for generations to come.

Innovations developed from highly engineered products and naturally sourced ingredients shape industries and everyday life. From smarter homes to more efficient cars, from better ways of digitally connecting to new tools that enable active and healthy lifestyles…in all these areas and many more, we’re working with customers to transform their ideas into real world answers that help humanity thrive.

Coupled with core values and excellent compensation & benefits… Together, we’re turning possibilities into real world answers that help humanity prosper!

Job

- Product Stewardship and Regulatory - Manufacturing

Primary Location

- NA-United States-Wisconsin-Madison

Organization

- Nutrition & Biosciences

Education Level

- Bachelor's Degree (±16 years)

Schedule

- Full-time

Employee Status

- Regular

Job Type

- Experienced

 

 

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