Full-Time

Boulder, CO

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Position Summary

The QA Document Control Specialist will provide documentation to support the Quality and Operations Teams to ensure that GMP standards, guidelines and procedures are being met and followed. This team member will perform a variety of general duties to assist in the day-to-day operations of the quality area providing documentation, record keeping, data entry, and compliance.

 

Qualifications

A high school diploma, GED, or equivalent with 3 or more years of Quality experience or equivalent combination of education and experience in Food and Drug Administration (FDA) specifically with Dietary Supplement, Food, OTC Regulations and GMP standards and guidelines.

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• Knowledge of principles, practices, methods and techniques of document and records management.

• Knowledge of and experience with computer and database applications used in records management programs (i.e., Access database experience, SharePoint, Trello, Smartsheet).

• Knowledge of and experience with MS Office specifically Word, Excel and Access database.

• Familiarity with project management.

• Strong attention to detail, accuracy and ability to multitask.

• Strong organization skills, with ability to set priorities and meet deadlines.

• Excellent verbal and written communication skills.

• Must be able to work effectively in a fast paced, team oriented environment.

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Responsibilities

• Responsible for document control processes that include maintaining of both electronic and hard-copied controlled documents and files as well as the historical tracking and audit trail of controlled documents.

• Maintain databases pertaining to document control process.

• Review controlled documents for accuracy.

• Maintain knowledge of the standard operating procedures (SOPs) for areas of responsibility.

• Understand procedures and processes to the extent that it is easy to recognize problems, recommend solutions and put the solutions into action.

• Complete assigned priorities and work assignments on time.

• Assist the QA Document Control Lead and Quality Manager in maintaining SOPs that pertain to areas of responsibility.

• Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals.

• Track data for reporting and analyzing trends and metrics for quality assurance.

• Other duties as assigned.

 

Position Type
This is a full-time position

 

Benefits
Innovae offers a complete and competitive benefit package designed for individuals and families.