QA Senior Specialist - Site Based, Redmond, WA
Cyprotex•Redmond, WA
5d•Onsite
About The Position
The Senior QA Specialist works cross-functionally to ensure compliance in operations to cGMP expectations and company SOPs. The Sr. Specialist is responsible for increasingly complex records and tasks, as well as training of junior personnel. The responsibilities of the employee is based on the assigned QA organization as outlined below.
Requirements
- Bachelor’s degree in biological or engineering science
- Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment and QC Lab.
- Ability to collaborate and communicate cross-functionally and at is higher levels.
- Must be able to show initiative and deliver results.
- Ability to work at faster and ever changing levels.
Responsibilities
- Review the QC testing and method transfer documents to ensure compliance with all regulatory requirements, company policies, values, and goals.
- Review QC owned quality records such as CAPAs, Stability protocols/reports, and other quality documents as required.
- Lead process improvements within the QA for QC.
- Support/drive cross-training across QC Labs.
- Audit/inspection support for QA QC Site department as required.
- Partners with other QA peers to ensure consistency and efficiency within the QA department.
- Alert senior management of significant quality, compliance, supply, and safety risks.
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- generous paid time off and paid holiday
- wellness and transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
