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Title

QA Document/Change Control Coordinator 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
Full-Time/Part-Time -unspecified-  
Description

This position will be responsible to administer, coordinate, maintain and secure controlled documents to ensure process and product related documentation meets operational needs and conforms to company standards as part of the change control process. The change control process encompasses changes in documentation, equipment, facility, specifications and test methods. This indivdual will be responsible for coordinating the implementation and documentation of changes with quality assurance, manufacturing and regulatory.

This position will also be responsible for the company training program, as well as, generating all new hire cGMP training files and conducting New Hire Orientation training.

Maintain the document control system consisting of product and process related documenation, such as, batch records, SOPs, test methods and specifications.

Write and revise Standard Operating Procedures (SOPs) as required.

Requirements

Bi-lingual Spanish/English is preferred

4 years of experience in regulated industry, such as pharmaceutical, Medical Device or biotechnology

Possess a considerable knowledge of cGMPs and SOPs

Strong computer skills and must be proficient in Microsoft Office, WORD, EXCEL, Power Point and Outlook

Demonstrate ability to work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take initiative and produce accurate and timely work.

 
Location Lenexa, KS  

This position is currently not accepting applications.

To search for an open position, please go to http://pineytechnicalservices.appone.com



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