Ensure the compliance of FDA regulations as it relates to quality specification of raw material components and finished product testing of dietary supplements and food products. Ensure proper quality procedures are followed and are updated as necessary. Ensure sanitation, food safety and quality programs are aligned with state and federal regulations through routine auditing.
1. Plan and conduct document review of supplement products, processes, or materials to include investigations, evaluations and confirmations of compliance.
2. Plan and conduct scheduled internal audits to assess compliance with FDA, HACCP, SQF and internal requirements; including SOP’s audits for compliance, consistency and relevance, incorporating best practice and auditing receiving of raw materials components, packaging materials and labels. Report on audit scheduling, investigation and evaluation of audit observation and findings, follow-up and confirmation of follow-up actions.
3. Ensure all raw material components compliance to dietary supplement regulations 21CFR111 and FSMA 21CFR117.
4. Manage Environmental Monitoring Programs within the facility. Communicate with corporate quality team to implement corrective actions.
5. Monitor all necessary laboratory analysis, provide technical support, compile and review all raw material components and finished product testing to ensure compliance to FDA dietary supplement regulations 21CFR111 and FSMA 21CFR117.
6. Identify and implement corrective actions to fully comply with dietary supplement regulations and SQF standards.
7. Provide instruction for special handling of raw materials and ensure all raw material components compliance to dietary supplement regulations.
8. Maintain up to date specification sheets for incoming raw material components for all tea products.
9. Support the plant in the preparation for and execution of 3rd party and FDA inspections.
10. Audit the compliance of the sanitation program.
11. Manage the plants allergen cleaning validation program.
12. Communicate quality, food safety and dietary supplement compliance concerns to operators, supervisors and managers, quickly and effectively.
13. Provide back-up support to the Analytical Laboratory, when needed. Performing all Analytical Laboratory testing functions.
14. Participation with quality and operations on policy/procedure/ guideline development.
15. Ensure and support company GMP policies.
1. Bachelor degree in a food science or related science (preferred) or associates degree in science with related experience.
2. 2-4 years experience in a high speed, food products manufacturing environment. (Dietary Supplement manufacturing experience preferred.)
3. Computer skills, demonstrated proficiency in Microsoft Excel and Word at an intermediate level, database management, math skills.
4. Problem solving, decision making, and leadership skills that help provide input into decision to reject specific packaging materials, monitor cGMP compliance, and keep plant sanitation standards high.
5. Demonstrated skills performing root cause analysis.
6. Reports/written communication
7. Ability to carry 10-20 lbs., and push/pull 60+ lbs.
8. Ability to meet attendance guidelines.
9. Ability to maintain an effective working relationship with all contacts both inside and outside the company.
At The Hain Celestial Group, our commitment to helping consumers lead A Healthier Way of Life™ is at the heart of everything we do. With operations in North America, Europe, and India, we participate in many natural categories with well-known brands. Our mission is to be the leading marketer, manufacturer, and seller of organic and natural, better-for-you products. We are committed to growing sustainably while continuing to implement environmentally sound business practices and manufacturing processes.
Come join one of Fortune’s 100 Fastest Growing Companies at our Celestial Seasonings location in Boulder, CO to help consumers lead A Healthier Way of Life™.
Please apply at http://www.hain.com/careers/