Quality Assurance Specialist
7 days ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Selkirk Pharma. As a key member of our Quality Unit, you will be responsible for ensuring the highest standards of quality and compliance in our operations.
Key Responsibilities- Develop and execute Supplier Quality and Compliance programs to ensure adherence to regulatory requirements and company policies.
- Conduct external audits, evaluate supplier risk assessments, and manage requalification schedules to maintain approved supplier databases.
- Manage and execute Compliance programs, including internal audits, client audits, and regulatory inspections, to ensure compliance with cGMP and regulatory guidelines.
- Develop and maintain site inspection readiness by conducting preparation sessions, mock inspections, and developing compliance data.
- Provide cGMP consulting services to internal and external clients, and support quality functions, including Deviations, CAPAs, Change controls, and continuous improvement initiatives.
- Bachelor's degree in a relevant field, such as science or engineering.
- Seven years of experience in Quality Unit functions within a government-regulated industry, preferably in the FDA pharmaceutical manufacturing environment.
- Experience developing, executing, and managing Supplier Quality and Compliance programs.
- Extensive knowledge of industry guidelines, including cGMP and regulatory guidelines.
- Professional certifications, such as ASQ Certified Quality Auditor, are highly desirable.
- A competitive salary range of $79,000 to $99,000 annually.
- A comprehensive benefits package, including medical, dental, vision, LTD, and Life and AD&D insurance.
- Stock options and a 401(k) plan with a 100% match on the first 3% and 50% on the next 2%.
- A cell phone stipend of $10 per month.
Selkirk Pharma is a leading manufacturer of injectable drug products, committed to providing safe and effective medication to patients worldwide. Our mission is to be the world's most reliable manufacturer, and we are seeking talented individuals to join our team in achieving this goal.
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Spokane, Washington, United States Jubilant HollisterStier LLC Full time{"Job Title": "Quality Assurance Compliance Specialist", "Job Description": "Jubilant HollisterStier LLC, a leading pharmaceutical and biopharmaceutical company, is seeking a Quality Assurance Compliance Specialist to support its Deviations, Corrective and Preventive Action (CAPA) program. The successful candidate will provide critical support to ensure...
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