Regulatory Affairs Associate

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Job description

SUMMARY:

To assist the Technical Services Manager in providing technical expertise and support services to Deerland Probiotics & Enzymes. To assist the Director of Quality Assurance in ensuring regulatory compliance and continual improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Attendance is key to performing the job.

1. Respond to information requests of a technical nature from outside customers and other company personnel.

2. Participate in literary research using institutional libraries, company archives, on-line services and other information sources to collect, record and analyze available information.

3. Evaluate collected data and prepare relevant data in suitable formats for dissemination to outside customers and in-house personnel.

4. Back up the Technical Services Specialist in generating technical statements including but not limited to, GMO statements, allergen statements, preservative/residual solvent statements.

5. Prepare or review various Quality Documents for accuracy, including but not limited to, Certificates of Analysis, raw material and finished product specification sheets.

6. Assist the Technical Services Specialist in generating FDA compliant Facts boxes for Deerland branded blends and customer formulations.

7. Assist the Technical Services Specialist in conducting label reviews.

9. Assist SORA laboratories in establishing/editing testing codes.

10. Manage/coordinate Deerland testing projects with SORA labs (includes but is not limited to, collecting, and transporting test samples, setting up testing request forms, receiving/collating test results.)

11. Manage/Maintain various archives for QC/Technical departments (included but not limited to, label review archives, and test result archives.)

12. Perform vendor CoA checks for incoming raw materials.

13. Annual review of Regulatory Standards including but not limited to, Food Safety, HACCP, Food Defense, 21 CFR 111 and 117, PIC/s.

14. Review of Regulatory records such as Investigations, CAPA's, Complaints, Change Controls to ensure documents are completed and initiate improvements, as necessary.

15. Prepare and Present GMP training on an annual basis.

16. Assist the Director of Quality Assurance in collection and presentation of Quality process for Management Review meetings.

EQUIPMENT USED:

Basic office equipment: Computer, Scanner, Copy Machine, Telephone, Printer, etc.

Requirements

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree (B.A.) in one of the following: Chemistry, Biology or Nutrition, from four-year college or university and one to two years related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret and extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

OTHER SKILLS & ABILITIES:

Must be self-motivated. Must be capable of organizing, scheduling and coordinating multiple projects simultaneously. Must be highly attentive to details.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is regularly required to sit; walk; stand; use hands to finger, handle, or feel objects, tools, or controls; reach with hands or arms; stoop, talk or hear; and taste or smell. Specific vision abilities required by this job include close vision and color vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT:

The noise level in the work environment is usually moderately noisy.

Other duties may be assigned by management.