Document Control Specialist

DEPARTMENT: UN QA/QC

REPORTS TO: Quality Manager

SUMMARY: Responsible for wide variety of duties related to documentation preparation and review while ensuring compliance to cGMP standards.

DUTIES AND RESPONSIBILITIES:

• Follow all Standard Operating Procedures and safety requirements in accordance with cGMPs.


• Maintains documentation process and filing system for quality assurance and regulatory activities.


• Manages documentation files, including storage and records retention that allows efficient and easy access.

• Conduct Batch Production Records and test results review and perform final product release.


• Create Certificate of Analysis.


• Interact and collaborate effectively with internal and external team members to assure needs of the company and clients are met.


• Assist in SOP (Standard Operating Procedure) review, routing for approvals, updating binders and filing.


• Assist in the implementation of Change control and Deviation program.

• Track and maintain employee training program, including training matrix and employee training files and records.


• Perform other similar or related duties as necessary assigned by management.

EDUCATION and QUALIFICATIONS:

• A minimum of high school diploma is required.


• Basic math skills.


• Ability to work effectively in a team environment.


• Detail oriented with a critical eye.


• Strong organizational skills.


• Legible charting and documentation skills.


• Proficient with Microsoft Office Programs.


• Knowledge and have experience using the ERP system.


• Basic knowledge of cGMP and dietary supplement/food regulations.


• Experience in food or dietary supplement manufacturing is ideal.


• Excellent grammatical and spelling skills.


• Versatility, flexibility, and a willingness to work within constantly changing priorities.


• Demonstrated ability to plan and organize projects.


• Ability to work independently and self-motivated.


• Ability to multitask.


• Ability to work in a fast-paced environment.

COMPETENCIES:

• Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.


• Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.


• Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.


• Change Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.


• Organizational Support--Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.


• Quality--Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.


• Dependability--Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to hours of work necessary to reach goals.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• 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. The employee is frequently required to stand; walk; use hands/fingers to handle or feel; reach with hands and arms and talk or hear. The employee is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift/move up to twenty-five pounds and occasionally lift and/or move up to fifty pounds. May work in warehouse/production environment as well as office area.