Regulatory Affairs Documentation Specialist I - 1st Shift

Description

SUMMARY

Provides documentation and regulatory support for NOW Foods products sold by our various sales divisions by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

· Provides the required technical documentation to support regulatory and registration requests for the NOW sales teams. This responsibility includes but is not limited to COAs, product specifications, vendor quality documents, allergen statements, non-GMO statements, product labels, Organic, Kosher and Halal certificates.

· Obtains technical information from QA/QC and company databases for the NOW sales teams to satisfy regulatory and registration requests.

· For documentation and registration work, reviews, proofs and confirms accuracy and correctness of documentation work based on various company documents, supplier information and other regulatory sites while ensuring conformance with GMP and other regulatory requirements. Alerts the manager and/or supervisor, quality and sales teams of any discrepancies found.

· Develop a tracking system and monitor accordingly ensure delivery of all required documentation at the expected deadline.

· Maintains regulatory and registration files of all work and documents provided to the sales teams.

· Complies with safety and GMP requirements.

SAFETY STATEMENT RESPONSIBILITY

Supports a culture of safe production and operations; follows all safety rules and procedures. Actively participates in the safety program by: engaging in training activities to learn what constitutes a safety hazard; reporting safety concerns to the supervisor; submitting safety suggestions; and correcting or reporting to the appropriate people when they see a workplace health or safety hazard, until it is resolved. Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan.

Requirements

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skills, and/or abilities required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Associate’s degree from a two-year college or bachelor's degree (BA or BS) from four-year college or university with a related degree in biology, chemistry, nutrition and/or quality/regulatory compliance preferred.

LANGUAGE SKILLS

Ability to read, analyze, and interpret published biomedical periodicals, professional journals, technical procedures, or patents is required. The ability to write routine technical reports, summaries of scientific research publications, and product information bulletins, and interpret data in English as well as Arabic. Good verbal and written communication skills are required, with an ability to effectively present and communicate technical information and respond to questions from groups of business managers, customers, consumers, scientists, and co-workers is essential.

OTHER SKILLS AND ABILITIES

Excellent interpersonal, organizational skills and attention to detail required. Good computer skills required, including proficiency with Word and Excel. Oracle and LIMS experience and other quality technical databases a plus.

MATHEMATICAL SKILLS

Ability to apply mathematical concepts such as probability and statistical significance, as well as the ability to apply fractions, percentages, ratios, and proportions.

REASONING ABILITY

Ability to interpret and solve problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is required to regularly use the telephone and computer. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT

Desk and office environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.