Quality Compliance Specialist,1st Shift
Portsmouth, New Hampshire | Contract
This company is one of the world' s leading suppliers to the Pharma & Biotech industries!
They are now looking for a Quality Compliance Specialist!
Please Apply now since they will be interviewing candidate' s ASAP.
The Quality Compliance Specialist Level 1 supports the department and site in publishing of metrics and reports and meeting coordination. The Specialist interacts directly with internal customers on change management documentation and projects while being mentored by a senior Compliance Specialist. Capable of identifying and resolving Quality issues with assistance. The specialist will ensure superior customer service to internal customers
Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings (daily department meeting, lot release, CCC coordinator, CC Approval Board, Q Council metrics).
Reviewer and final approver on SOPs, forms, test methods, logs within Document Management System. Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference.
Reviewer and final approver on non DMS documents (executed work order, Environmental Action Reports)
Review and final approver on Validation Protocols and Summary reports for CIP, SIP, new equipment/instrumentation, and computer systems.
Bachelor’ s Degree or equivalent experience)
Preferred area of study: Scientific related field
1-2 years in GMP environment preferred
Biotechnology manufacturing background is preferred