Mgr., Qual Change Control & Doc (I) in Bohemia, NY at The Nature's Bounty Co.

Date Posted: 5/21/2018

Job Snapshot

  • Employee Type:
  • Location:
    Bohemia, NY
  • Job Type:
  • Experience:
    At least 7 year(s)
  • Date Posted:

Job Description

Company Description  

For more than 70 years, The Nature’s Bounty Co. has enriched the lives of consumers around the world and stood as the leader in health and wellness by introducing innovative products and solutions to the marketplace. Putting science and the highest quality standards at the heart of our business, the brands of The Nature’s Bounty Co. are some of the most trusted in the world. Always motivated by nature’s bountiful effects on people’s health, our vision for health and wellness has inspired leading brands such as Nature’s Bounty®, Sundown Naturals®, Solgar®, Osteo Bi-Flex®, Ester-C®, MET-Rx®, Pure Protein®, Balance®, Body Fortress®, Puritan’s Pride® and Organic Dr.®, among others. As a leading global manufacturer, marketer, distributor and retailer of vitamins, nutritional supplements, sports & active nutrition and ethical beauty products, The Nature’s Bounty Co. is committed to supporting wellness in all its forms.

Job Description  

The Manager of Quality Change Control & Documentation is responsible for managing quality systems including change control and documentation management. As a member of the Global Quality Compliance group, this associate will provide global oversight and guidance of Change Control and Documentation processes and ensure that appropriate metrics are in place to measure compliance, effectiveness and opportunities to improve. 

Additional responsibilities will include:

  • Creating, managing and updating SOPs and associated programs and guidance documents to ensure they are accurate and easy to use
  • Managing and improving change control and documentation processes to ensure The Nature’s Bounty Co. is an industry leader in the areas of their responsibility, and is compliant with all applicable regulatory and customer requirements
  • Develop, review, update, improve, refine, and maintain Change Control and Documentation related to Nature’s Bounty processes, policies, procedures, and standards
  • Development and maintenance of standard procedures for documenting, operating, and reporting within the Change Control processes; as well as maintaining all related records (software, hardware, application and documentation)
  • Ensures that company documents are routed, reviewed, approved, controlled and implemented in accordance with established procedures
  • Reviews documents for accuracy and completeness in formatting and content
  • Maintain, update and modify Change Control plans and procedures to document the functions and processes used by the Nature’s Bounty locations
  • Ensures compliance with Change Control & Documentation Management policies meet regulatory agencies guidelines
  • Ensures company records are retained and available for use in accordance with established procedures
  • Support internal and external audit activities including FDA Inspections, Customer audits and USP/UL certification/surveillance audits
  • Develop and/or maintain policies/procedures for change review board meetings
  • Coordinate, schedule, conduct, and facilitate change review board meetings to include, but not be limited to, review of planned changes and results of changes made, ensuring that all appropriate parties are invited and represented in accordance with approved board policies
  • Supports the maintenance of compliant, effective and efficient change control, document control and record retention processes across the organization
  • Works both cross functionally and across sites with a sense of urgency to ensure the compliance and effectiveness of the global Change Control and Documentation systems
  • Establish Change Control Management metrics and reporting.
  • Write summary reports, create action plans and implement tracking measures to verify effective completion
  • Interface closely with Operations (Manufacturing & Packaging), Technical Services, R&D, Product Development, Regulatory and Nutrition, IT, Legal, Operations, Sales, Distribution and Procurement teams

  • Minimum of 7 years of experience in the industry (food, pharmaceutical, medical device or dietary supplements)
  • Minimum 5 years of experience in FDA regulated environment
  • Minimum 3 years of experience in management and/or establishment of Quality Systems
  • Experience working with quality systems in both a manufacturing and corporate environment
  • Proven track record of transforming systems and organizations for improvement in compliance and efficiency
  • Management experience, including strategic planning and project planning, project management, and problem-solving skills
  • Bachelor’s in Chemistry , Food Science, Chemical Engineering or Science related field required or other closely related discipline with extensive significant experience can be considered in lieu of a Science related Bachelor’s degree
  • Ability to data mine Oracle PQM and other database
  • Fluent in applications such as MS Excel, Word
  • Good planning and organizational skills
  • Ability to write policy and procedures
  • Ability to lead, train, motivate, and develop successful teams
  • Excellent oral and written interpersonal communication skills
  • Ability to work collaboratively within teams
  • Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
  • Continuously look for ways to do things faster and better, while maintaining high quality standards
  • Is creative and intellectually curious; tries different and novel ways to solve obstacles
  • Effective at analytical thinking/ problem solving
  • Demonstrated knowledge of manufacturing systems and processes
  • Innovation, Continuous learning, continuous improvement
  • Change management
  • Prioritization and decision making
  • Influencing others

Additional Information  

The Nature's Bounty Co. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

The Nature's Bounty Co. offers a competitive salary and a comprehensive benefits package, which includes health and dental plans, voluntary short-term and long-term disability, life insurance, flexible spending accounts, 401(k), tuition reimbursement, generous associate discounts and more! 

Please contact Human Resources at 631-244-2120 if you should need a reasonable accommodation to submit your information for our online job postings.