Senior QA Specialist
Newark Metro Area, NJ
Main responsibilities are reviewing and approving IOQ qualification documentation for lab instruments, process equipment, facility and utilities for drug product and biologics clinical manufacturing.
Other responsibilities will include, but are not limited to, the following:
1. Conducts QA review and approve all manufacturing/processing batch records and quality test records.
2. Ensures completeness and accuracy of all files received into Quality Assurance, according to SOP and to meet state and federal regulatory requirements.
3. Ensures readiness of records for regulatory inspection.
4. Completes and provides data for Continuous Quality Improvement for all batch and quality test records per SOP.
5. Revises existing standard operating procedures as needed for annual review and process changes.
6. Reviews proposed changes to existing Standard Operating Procedures as needed
7. Assists in the review and release of raw materials for use in the manufacturing/laboratory area
8. Coordinates back room activities for Regulatory Inspections.
9. Reviews, compiles and organizes data for trending.
10. Provides assistance to other QA staff members as needed.
11. Performs other QA duties as assigned.
Bachelors degree in a Life Science and/or equivalent work experience.
Basic understanding of medical terminology and/or cell therapies. Detail oriented with high degree of focus.