The Regulatory Specialist is responsible to oversee regulatory and documentation processes.

• Ensure compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117, and Global Food Safety Initiative (GFSI) scheme;
• Oversee and maintain internal specifications for the creation of manufacturing documentation;
• Oversee and maintain Master Manufacturing Record (MMR) documentation;
• Review and approve completed production work orders;
• Ensure clear intradepartmental communication;
• Work with regulatory agencies to gather documentation and regulatory certificates;
• Proof read/review label content and refine review process as needed.
• Manage Supplier Qualification process
• Set up internal procedures to certify products with regulatory agencies;
• Manage manufacturing documentation revisions, including change control and deviations;
• Ensure products are compliant based on final delivery form and region of distribution;
• Write regulatory processes and work with Quality Management to develop new quality processes;
• Meet goals and objectives as outlines by the Executive Management team;
• Follows cGMP guidelines and processes as established in company & departmental SOPs;
• Perform other duties as deemed necessary.

• High School Diploma required and some college experience preferred;
• 1-2 years’ experience in a similar setting;
• Detail oriented and highly organized;
• Experience working with outside regulatory agencies;
• Working knowledge of Microsoft office and general computer concepts;
• Intermediate math, communication, and problem solving skills;
• Strong documentation practices and record keeping skills;
• Excellent written and oral communication skills;
• Ability to type 35 wpm;
• Ability to follow company processes and procedures;
• Ability to work without direct supervision;
• Ability to sit for extended hours;
• Ability to view a computer screen and type for extended hours;
• Work environment is normally in an office setting. Must be able to make frequent rounds in a warehouse environment;
• Ability to work around a variation of different smells and aromas;
• Other physical requirements include occasional squatting, bending, twisting, and bi-lateral hand and wrist movement;
• This position may require infrequent travel;
• Ability to adjust to work schedule as business needs require.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.