Senior Quality Assurance Specialist (Permanent)

As the QA Specialist your main responsibilities will be to:

1. Perform QA on-the-floor batch record review responsibilities including in-process batch record review, execution of QA walkthroughs, performance of line clearance, and in-process / final product inspections.
2. Review and approve GMP documentation against SOPs (Standard Operations Procedures) to ensure manufacturing steps are appropriately documented, observations are clear, and Good Documentation Practices are followed.
3. Conduct GMP area in-process audits and walkthroughs of GMP areas for detection of non-compliance issues, inspection risks, and procedural or GMP non-compliances.
4. Perform assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
5. Partner with Manufacturing Operations to meet schedule requirements and resolve challenges.
6. Review and approve and support timely closure of Quality Systems