Quality Assurance Specialist
Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
1. Maintains documentation filing systems for security, confidentiality and ease of use. Files, tracks and/or retrieves archived information on a routine basis. Maintains the archive system for off-site storage so that documents, records and files can be easily retrieved for audit and review purposes.
2. Conducts QA review of various types of files, include Biologics, records and batch records for completeness and accuracy according to SOP. Notes and sets activities for all required follow-up. Follows-up to verify completion of activities.
3. Updates logs, databases and catalogs including, but not limited to, SOP Manuals, Training Records and SOP History Files.
4. Completes and provides data for Continuous Quality Improvement for all records reviewed per SOP.
5. Provides input/suggestions for revising standard operating procedures during annual review and process changes.
6. Coordinates the application and renewal processes for state and regulatory licenses, registrations and permits.
7. Reports non-conformances and/or quality related issues when observed.
8. Provides assistance to other QA staff members as needed.
9. Performs other QA duties as assigned.
Skills/Knowledge Required: Must have Biologics batch record review experience. Basic scientific understanding. Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal. Basic math skills. Able to perform with minimal supervision and contribute in a team environment. Able to communicate results and issues effectively, both written and orally. Able to exercise judgment within defined procedures. Basic knowledge and ability in using Microsoft Office Package.