QA Specialist

Duties may include oversight of various aspects of change control and documentation, including but not limited to change control administration, records management, document control, local change control, and corporate change control. As a member of the Quality unit this individual is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems. The Change Control Plant QA Specialist may also be responsible for the review and approval of SOPs and documents related to site GMP facilities, equipment and utilities as well as Validation documents. The Change Control Plant QA Specialist may also be responsible for daily technical support for change control and document control activities of the Documentation Technicians.