Responsibilities of this position:

·         Perform compliance review of study protocols, validation documents, and controlled documents (SOPs, TMs, Specifications, Change Controls, Batch records) to internal company documents and external regulations.

·         Create and/or revise departmental SOP’s.

·         Assist in internal audits.

·         Coordinate and compile documents for the product specification file for clinical material used in studies complying with European Commission directives.

·         Assist with training and acting as a department liaison to help facilitate the resolution of quality issues or questions.

·         Provide guidance to other lower-level QA Specialists.

·         Work with Change Control Review authors to prepare and facilitate review of major change request. Ensure that CCRs submitted meet CCR requirements and are suitable for review. Ensure that approved and closed CCRs are accurately updated in the document control system in a timely manner. Facilitate company use of required CCR preparation processes and documentation systems. Manage all aspects of CCRs reporting as needed.

·         Ensure that document content, formatting, and organization meets requirements and retains technical accuracy.

·         Facilitate company use of required documentation preparation processes and documentation systems. Manage all aspects of document conversion process as needed.

·         Prepare and/or incorporate changes, release, storage, distribution, and archive of controlled files (including: SOPs, process instructions, protocols, reports, specifications, methods analysis, logbooks, and notebooks).

·         Implement improvements in current document control systems, provide written procedures, reviews and comments on related documentation procedures, and ensures their proper implementation.

·         Communicate with appropriate departments to ensure changes are well documented and easily understood.

·         Interact with appropriate departments to establish priorities and deadlines for processing requests.

·         Ensure the correct and timely implementation of requests and coordinates the resolution of problems. Develop and communicate both drafting standards and change control process standards.

·         Responsible for observing all Company, Health, Safety and Environmental guidelines.