Quality & GXP Compliance Associate

Assist in the control, review, approval, distribution, and administration of policies, standard operating procedures, controlled forms, batch records, specifications, test methods, label masters, worksheets, lab reports and other controlled documents as necessary. Ensure compliance to applicable company policies, standards and regulations.

* With knowledge of fundamental theories, principles, and concepts, performs structured work assignments in order to develop competence and functional acumen in his/her area.
* Communicates potential compliance issues or problems to the Quality Assurance Documentation Manager, Operations or Senior QA personnel in a timely manner providing sufficient details and supporting information.
* Perform filing of departmental documents for the team.
* Assist in the processing and execution of documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices.
* Work in MasterControl electronic Document Management System.
* Ensure the proper distribution of and access to approved documents and maintain controlled documents.
* Coordinate with appropriate departments to ensure all applicable documents are reviewed and revised within the specified review and revision timeframes.
* Distribute electronic templates to document originators in order for proposed documents to be drafted.
* Circulate proposed documents for review, coordinating with all appropriate departments to ensure correct departments are involved in the review.
* Circulate final versions of proposed documents for approval, coordinating with all appropriate departments.
* Withdraw/retire controlled documents, as necessary.
* Coordinate with Training to ensure applicable departments/individuals are notified when documents are approved.
* Assist with the control and maintenance of files.
* Provide clerical and administrative support related to documentation.
* All other duties as assigned.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.