Senior Specialist, Quality Assurance Chemist II
1 week ago
This is a challenging and rewarding opportunity to join Cardinal Health as a Senior Specialist, Quality Assurance Chemist II. As a key member of our Quality Control team, you will play a critical role in ensuring the quality and safety of our products.
Key Responsibilities- Quality Assurance and Control: Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
- Sample Analysis: Conduct thorough inspections and analysis of incoming materials, drug substance, in-process, and drug product samples to ensure compliance with specifications and standards.
- Investigations and Deviations: Perform investigations, deviations, change controls, and CAPAs to identify and resolve quality issues.
- Method Verification and Validation: Execute method verification, validation, and/or transfer protocols to ensure the accuracy and reliability of analytical methods.
- Stability Testing: Perform stability testing in alignment with stability protocol(s) at the prescribed cadence to ensure the quality and safety of our products.
- Documentation and Training: Author standard operating procedures, analytical method worksheets, forms, and other documents as necessary and applicable. Train others on SOPs, protocols, instruments, and quality guidelines.
- Collaboration and Communication: Work closely with cross-functional teams, including production, quality, and regulatory, to ensure seamless communication and collaboration.
- Education: Bachelor's degree or previous work experience in a similar role or related field, such as chemistry or biology.
- Experience: 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA-regulated industry (pharmaceutical or medical device) preferred.
- Skills: General knowledge of GDP documentation practices and requirements, experience in authoring various forms of documentation, strong technical writing skills, proficiency in Microsoft Word and Excel, and excellent communication and collaboration skills.
- Competitive Salary: $67,500-$95,000
- Benefits: Medical, dental, and vision coverage, paid time off, health savings account, 401(k) savings plan, access to wages before payday, flexible spending accounts, short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.
Cardinal Health is a leading healthcare company that provides products and services to healthcare providers, pharmacies, and manufacturers. We are committed to improving the quality and safety of healthcare through our innovative products and services.
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