QA Document Coordinator

• Medical
• Dental
• Vision
• LTD
• 401K matching
• Life & Supplemental Insurance
• Paid Time Off (Vacation, Personal & 8 Holidays)
• FSA
• Flexible 4/10 work schedule
• In house Gym

SUMMARY: Responsible for maintaining Document Control Procedures and Practices. Provides assistance to the QA Manager and Quality Assurance Department by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 Issue, review, updates company documents (SOPs), manufacturing (batch records) and regulatory procedures in accordance with company Document Control process. Keeps in order all relevant documentation files.  Distributes all newly issued and revised documents to the appropriate/relevant users and departments.

 Keeps track of received data and source documents such as: QC Specification sheets for raw materials, bulks and finished products, Certificates of analysis and Safety Data Sheets.

 Works with other source documents such as: product formulas, vendor qualification documents, raw materials technical sheets, and product identification information to include and update part numbers, shelf life, etc. in Oracle inventory system when needed.

 Assists in the review and approval of the company Art work files including but not limited to labels, boxes, jars and other primary and secondary packaging components.

 Helps prepare documents and certificates requested by legal department for product registration and reregistration.

 Assists with facility GMP audit reports as assigned by the QA manager.

 Assists in the review and approval of production paperwork and batch records by doing Yield and Accountability calculations and checking the documents for completeness and accuracy in accordance with GLP and GMP practices.

Maintains GMP training schedule for all company employees and keeps record of the completed trainings.

 Keeps records of Customer complaints investigations and OOS investigations and department’s Calibration and Validation activities. Fill out and complete the corresponding paperwork.

 Fills out deviations and rework instructions and issues them to the appropriate/relevant departments.

 Collects, tracks, trends and analyzes recorded data and draw sound conclusions.

 Reports quality and/or safety trends and potential issues to Quality management and participate in investigations as necessary.

 Maintains QA documentation (papers and e-files) well organized, up to date and audit ready.

 Participates in Quality System audits by helping to retrieve the necessary and relevant documents.

 Implements new and efficient ways to document and archive.

 Stay up to date with current CFR pertaining to food, dietary supplements, cosmetic and drugs.

 Other duties and tasks as assigned by QA manager.

SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE High School Diploma or GED and some college (science based courses preferred). Minimum 3-year of hands-on experience as Quality Assurance documentation in cGMP environment; preferably in a pharmaceutical, nutraceutical or food manufacturing industry. Experience with document control, batch record review.

LANGUAGE SKILLS Fluent in reading, writing and speaking the English language as well as having experience with technical writing (knowing Spanish a plus). Ability to read, analyze, and interpret technical instructions or writings. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees.

MATHEMATICAL SKILLS Ability to apply simple mathematical operations to such as calculating average of numbers, fractions, percentage, variation, etc.

COMPUTER SKILLS To perform this job successfully, an individual should have proficient knowledge of Database software; Spreadsheet software and Word Processing software such as Microsoft Word, Excel and archiving software.

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

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 frequently required to sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste or smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT The work 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.

While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet.