Senior Specialist, Quality Assurance (Nights)

Cardinal Health

85d • $67,500 - $96,400

About The Position

Quality Assurance contributes to Cardinal Health Quality by developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures, ensuring that all products and services are properly reviewed for quality and documented. Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Requirements

• Bachelor's degree in related field, or equivalent work experience, preferred.
• 2-4 years of experience, preferred.
• 1-2 years of experience in Quality Assurance and/or cGMP regulated environment preferred.
• Effective written and verbal English communication skills.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Ability to lift up to 30-45 lbs.
• Ability to manage several tasks at the same time and evaluate operating conditions.

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related to products and processes as deemed necessary by the RQM.
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
• Engages and collaborates with operations department to drive quality system and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Reports quality system issues to the Regional Quality Manager, including timely escalation of discrepancies upon identification.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees