Quality Documentation Specialist 2

Sr. Change Control Analyst

Responsibilities:

·         Monitoring changes status.

·         Chairing meetings with Corporate to address issues and following up on Change Control process.

·         System Library Manager functions.

·         Providing solutions to changes issues.

·         Ensuring that changes are approved correctly, assigning users to each role

·         Obtaining changes metrics.

·         Training users on Change Control (Reynosa Facilitator).

·         Providing Change Control access to users

·         Processing Reynosa Change Control Notifications in the Windchill system and GPDM.

·         Creating a placeholder for new documents on Windchill system and GPDM.

·         To maintain documentation databases updated.

·         When necessary, performing revisions to the documents in the system. Assembles technical documents according to established procedures and guidelines. Implements and maintains standard operating procedures. Makes recommendations for improvements as necessary.

·         Will Support Sr. Documentation Systems Manager with other functions as assigned, such as reports, databases and document control technical information.

·         Tracks and distributes Change Control Notices (CCNs) to maintain trail of new and revised documents to ensure compliance with regulations and SOPs.

·         Process and makes approved changes to affected documents (including drawings, bill of materials, specifications, and product labeling).

·         Writes and implements changes per local procedure, as well changes to correct errors or typos. Obtains proper approvals to change documents.

·         Employee must be trained according to the curriculum assigned by the training department.

·         This position will be required to support and respond to internal audit observations and corrective actions. Timely and proper response to these requirements will be tied directly to annual performance reviews.

·         Maintains current knowledge of FDA and GMP standards/requirements for medical drugs and devices to ensure compliance.

Qualifications:

·         Bachelor’s degree

·         Minimum 1 year of experience in similar position

·         Bilingual English / Spanish.

·         Excellent oral and written communication skills.

·         Good Bilingual communication skills (written and oral).

·         Good computer skills and software packages knowledge: Windchill System, GPDM, MS

Office, MS VISIO, AutoCAD and SolidWorks.

·         Good data entry skills. Databases (desirable)