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Senior Specialist, Quality Assurance Expert
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Cardinal Health. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.
Key Responsibilities- Quality Policy Development: Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
- Quality System Implementation: Develop and implement a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective.
- Quality Oversight: Provide oversight of production/manufacturing activities, training to operational and quality control personnel, and educate business leaders on quality policies and procedures.
- Documentation Review: Handle cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Metrics Reporting: Establish and report metrics related to products and processes as deemed necessary by the Regional Quality Manager.
- Quality System Maintenance: Ensure the site manufactures products to meet the requirements of 21 CFR 212 (cGMP) and handle and ensure quality of documentation (control, retention, and archival) to support cGMP activities.
- Collaboration and Communication: Engage and collaborate with operations department to drive quality system and cGMP requirements, perform product release activities per cGMP requirements, and report quality system issues to the RQM and others as necessary.
- Education: Bachelor's degree in a related field (science) preferred, or equivalent work experience preferred.
- Experience: 2+ years of experience in a related science field preferred, 1-2 years of experience in Quality Assurance and/or cGMP regulated environment highly preferred.
- Skills: Effective written and verbal English communication skills, ISO experience a plus, ability to lift up to 30-45 lbs.
The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.
What We Offer- Competitive Salary: Anticipated salary range: $67,500-$96,400.
- Benefits: Medical, dental and vision coverage, paid time off plan, health savings account (HSA), 401k savings plan, access to wages before pay day with myFlexPay, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, healthy lifestyle programs.
