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Senior Specialist, Quality Assurance Expert
2 months ago
We are seeking a highly skilled Senior Specialist, Quality Assurance to join our team at Cardinal Health. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and safety of our products and services.
Key Responsibilities- Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
- Lead the development and implementation of a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective.
- Provide oversight of production/manufacturing activities, training to operational and quality control personnel, and educate business leaders on quality policies and procedures.
- Ensure that all products and services are properly reviewed for quality and documented.
- Perform all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility.
- Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Establish and report metrics related to products and processes as deemed necessary by the Regional Quality Manager.
- Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
- Handle and ensure quality of documentation (control, retention, and archival) to support CGMP activities.
- Engage and collaborate with operations department to drive quality system and CGMP requirements.
- Perform product release activities per CGMP requirements.
- Monitor CAPA in investigations and close when completed or escalate (if necessary).
- Perform aseptic review of the site with operations and document results.
- Report quality system issues to the RQM and others as necessary.
- Bachelor's degree in a related field, or equivalent work experience.
- 2-4 years of experience in quality assurance or a related field.
- Proficiency with MS Excel and MS Word.
- Effective written and verbal English communication skills.
- Strong attention to detail.
- Ability to lift between 30-45 lbs.
- Pharmaceutical or medical device experience a plus.
- ISO experience a plus.
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- A competitive salary range of $74,500-$106,400.
- A comprehensive benefits package, including medical, dental, and vision coverage, paid time off, health savings account, 401k savings plan, and more.
