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QA Document Control Specialist

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Opening: May 12, 2021
Closing: June 12, 2021

About the job

The QA Document Control Specialist will provide documentation to support the Quality and Operations areas 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.

What you will be doing

  • 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. 

Skills and experience we would like to see

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.

  • 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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Apply

After you have taken the time to review our open positions, you may be curious to discover how your talents align with shaping the future of Modere. You are more than just your resume. We understand. The resume is only the introduction to your story. A platform to begin a conversation.

So, are you ready to introduce yourself? Let's begin. Send us your resume and any additional links you would like for us to review. Feel free to begin with a brief intro. A standard cover letter just won’t do. We invite you to let us know what you are thinking at this very moment.

After you submit your information, time will elapse as we review responses. As we learn about you, we may discover that our paths intersect and we will want to meet you. It may be over the phone or in person. Be prepared. It is critical that you understand that we are selective. (We expect you are as well.)

This is an excellent time for you to reflect. Know who you are. Be comfortable being you. Know what drives you to be your best. Know what kind of people motivate you to be your best. Why are you considering a change of employment? What would a Modere employment opportunity mean for you?

Apply

jobs@m-careers.com