The position of Quality Assurance Specialist II is within our Infectious Disease Business
Unit located at Scarborough, Maine. In this role you will, under minimal direction, perform a wide variety of activities to support the Quality Management System.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
The following activities may be assigned as applicable:
Quality System Management
Review production batch records (DHRs) for accuracy and completeness in order to
approve intermediate products for use in production. Review finished goods batch
records. Report deviations in these records and assure they have been addressed and
resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Participate in the internal audit program
Write, review and approve Standard Operating Procedures (SOPs) as necessary
Assist with and may wri...