All compliance work and paperwork. You have got to be a real “thinker” for this position. You will need to interface with most other departments. Heavy computer and paperwork, and coordinating and implementing the compliance yourself in many cases.
Our company has high standards for ingredients. These standards include using the highest quality, vegan, plant-based botanicals and botanical extracts that are pesticide, irradiation, solvent, and GMO free. We also manufacture without excipients, fillers, or any chemicals. Our company has high ecological and environmental standards related to any chemicals or materials used in the facility for a safe environment for the staff, the finished product, and the outside environment. Most of our products are bottled in glass packaging. The person we are seeking can work with these high standards and help create solutions that comply with existing regulations.
Important Note: Excelsior is a medium sized family based company and we are looking for someone who wants to grow with us. This may mean that pay will not be as high as industry expectations.
COVER LETTER CRITICAL – Explain why you are a fit for the position, why you want this position, and how you fit with the vision for this company. Generic applications will be deleted.
- Directs and manages activities related to process and product compliance with applicable food laws and regulations. (cGMP 21 CFR 111)
- Perform internal audits and ensure corrective actions are implemented.
- Review calibration logs as per the schedule. Schedule calibrations/ certifications as needed.
- Update training documents, perform cGMP training for all personnel needs.
- Create and Revise SOPs, Forms, and Specifications as needed
- Review batch records, incident forms and other documentation.
- Perform root cause analysis when needed to investigate incidents and offer solutions to the team.
- Prepares timely and accurate responses to inquiries regarding the regulatory status of our products, the ingredients they contain, and the processes we use to produce them.
- Assists in the development of systems and procedures.
- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving challenges.
- Communicates with government agencies on matters affecting our regulatory compliance.
- Manages and develops QA/QC staff by providing direction, technical expertise, and training.
- Communicate lab tests, specifications, etc. to management, manufacturing personnel, purchasing, and sales representatives.
- Full time at the Tempe, Arizona, location
Desired Skills and Experience
- Ability to read, write, and speak both English and Spanish (not essential).
- Possess perseverance when interacting with government agencies and regulatory environments.
- Ability to monitor and influence external forces to ensure the company’s interests are maintained.
- Knowledge of regulatory environment and how it affects food ingredients and the company’s process and products. Ability to understand and interpret regulatory requirements and devise and implement procedures for communication and compliance.
- B.S. or M.S in physical or life sciences.
- Two+ years of quality supervision work in food, feed, pharmaceutical, or dietary supplements.
- Willingness to perform in depth research about test methods, ingredients, products etc.
- Experience with analytical chemistry techniques (particularly Thin Layer Chromatography) is a bonus.
- Health Insurance
- 2- Weeks Paid Vacation (first year accrual)
- Holidays: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Christmas Day, Good Friday