Senior Specialist, Quality Control Chemist II
3 days ago
We are seeking a highly skilled Quality Control Specialist, Chemistry to join our team at Cardinal Health. As a key member of our Quality Control department, you will be responsible for ensuring the quality and integrity of our products and processes.
Key Responsibilities- Perform inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples to ensure compliance with regulatory standards and specifications.
- Investigate deviations, change controls, and CAPAs to identify and implement corrective actions.
- Execute method verification, validation, and transfer protocols to ensure the accuracy and reliability of our testing methods.
- Perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
- Author standard operating procedures, analytical method worksheets, forms, and other documents as necessary and applicable.
- Train others on SOPs, protocols, instruments, and quality guidelines.
- May execute analytical equipment qualification protocols or computer system validation test scripts.
- Bachelor's degree or previous work experience in a similar role or related field, such as chemistry or biology.
- 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
- General knowledge of GDP documentation practices and requirements.
- Experience in authoring a variety of forms of documentation, such as SOPs, Change Controls, CAPAs, Deviations, and Laboratory Investigations.
- Strong technical writing skills and proficiency in Microsoft Word and Microsoft Excel.
- A competitive salary range of $67,500-$95,000.
- A comprehensive benefits package, including medical, dental, and vision coverage, paid time off, and access to wages before pay day with myFlexPay.
- A collaborative and inclusive work environment that values diversity and promotes professional growth and development.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.
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