Senior Specialist, Quality Assurance

What Quality Assurance contributes to Cardinal Health

Quality develops and implements 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 and ensures that all products and services are properly reviewed for quality and documented.

Cardinal Health Positron Emission Tomography (PET) Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

• 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 products and processes as deemed necessary by the Regional Quality Manager (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 RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

• Onsite in Dallas, TX.
• 40 hours per week. This is a night position. Typically, Monday – Friday between either 2:00 am
  -10:00 am or 6:00 am-2:00 pm and every other Saturday.
• Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day. Work hours may be subject to change.
• Position may require approximately 25% travel to provide QA coverage when needed.

• Bachelor’s degree in related field preferred, or equivalent work experience preferred.
• 2+ years of experience in related science field preferred
• 1-2 years of experience in Quality Assurance and/or cGMP regulated environment preferred
• Pharmaceutical or medical device experience a plus.
• 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. The facility is operated under well‑controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group.
  
  Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlex Pay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

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