Location: Summit, New Jersey, United States
Sectors: Quality & Supply Chain
Job Type: Contract
Title: QA Specialist
Contract Length: 6 Months
Location: Summit, NJ
Responsibilities will include, but are not limited to, the following:
- 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.
- 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.
- Updates logs, databases and catalogs including, but not limited to, SOP Manuals, Training Records and SOP History Files.
- Completes and provides data for Continuous Quality Improvement for all records reviewed per SOP.
- Provides input/suggestions for revising standard operating procedures during annual review and process changes.
- Coordinates the application and renewal processes for state and regulatory licenses, registrations and permits.
- Reports non-conformances and/or quality related issues when observed.
- Provides assistance to other QA staff members as needed.
- Performs other QA duties as assigned.
- 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.
Sthree US is acting as an Employment Business in relation to this vacancy.