Quality Assurance Specialist
Newark Metro Area, NJ
Looking for QA Specialist with utility, facility, lab instrument, manufacturing equipment commissioning, IOP/Q experience to review an approve protocols, executed data packs and summary reports.
Responsibilities will include, but are not limited to the following:
1. Conducts QA review and approvals of facility, utility, lab instruments, manufacturing equipment commissioning and IOP/Q protocols, executed protocols, summary reports, SOPs, and batch records for completeness and accuracy according to cGMP.
2. Author QA operational SOPs.
3. Completes and provides data for Continuous Quality Improvement for all records reviewed per SOP.
4. Provides input/suggestions for revising standard operating procedures during annual review and process changes.
5. Reports non-conformances and/or quality related issues when observed.
6. Provides assistance to other QA staff members as needed. Skills/Knowledge Required: prior qualification and validation experience are preferred. Will consider candidates with operational and/or QA experience in analytical lab instruments, manufacturing of drug substance, drug product or biologics.
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.