Senior QA Specialist, GMP
Our Client, a multi-faceted pharmaceutical company in Seattle, has a permanent opening for a Quality Assurance Specialist to work with their quality team!
- ?Conducting audits of CMOs, CROs, and other service providers, writing audit reports and following up on observations/CAPAs
- Performing in-phase inspections in support of GLP studies, writing inspection reports, following up on observations/CAPAs, and preparing QA statement
- Reviewing GMP controlled documents such as master batch production records, test methods, specifications, and managing the implementation of required changes to meet GMP and internal standards
- Reviewing executed batch production records ensuring compliance with approved procedures and GMP expectations as well as communicating and resolving discrepancies with the CMO
- Reviewing release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
- Providing support in the review of change controls related to manufacturing
- Providing QA support for validations including reviewing protocols and reports
- Working collaboratively with Development, Manufacturing and QC staff, responding to and resolving deviations and incidents
- Following through on corrective and preventative actions from deviations, OOS and audit observations
- Maintaining databases for investigations, audit observations and CAPAs
- Review, analysis and trending of data related to production, testing and stability
- Writing and reviewing Standard Operating Procedures
- You’ll need to have a BS and/or MS degree in a Science and 5 years of related experience in Quality Assurance or a related area.
Additionally, we are seeking candidates with the following experience:
- Prior audit and batch record review experience
- In-depth knowledge and experience with GMP and GLP regulations and industry standards (USP, Ph.Eur., ICH, FDA, EU guidance)
Ideal Candidates (As our ideal candidate, you’ll need the follow skills and knowledge):
- Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software as well as internet search engines
- Demonstrated analytical and problem solving skills
- Detail orientation, organizational skills and the ability to prioritize multiple tasks
- A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
- Excellent interpersonal, verbal and written communication skills
- Occasional overnight travel is required.