Chemical/Pharmaceutical, Quality Assurance

About the Role

Cardinal Health PET Manufacturing Services manufactures PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Quality Assurance Contribution

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective.

Key Responsibilities

• 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.
• Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities.
• Engage and collaborate with the operations department to drive quality system and CGMP requirements.
• Responsible for product release activities per CGMP requirements.
• Responsible for reporting quality system issues to the regional RQM, including timely escalation of discrepancies.

What is expected of you and others at this level

• 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 actions to resolve them.
• Applies judgment within defined parameters.
• Receives general guidance; may receive more detailed instruction on new projects.
• Work is reviewed for sound reasoning and accuracy.

Requirements & Tech Stack

• Demonstrates knowledge of quality systems and approaches.
• Demonstrates an understanding of relevant regulations, standards, and operating procedures.
• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
• Demonstrates an understanding of requirements and ability to perform gap assessments.
• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and/or statistics, trending, quality planning, validation, CAPA, and problem-solving.
• Works cross-functionally and has the ability to interpret requirements, educate, and influence others.
• Ability to manage several tasks simultaneously.
• Ability to focus on tasks.
• Ability to evaluate operating conditions.
• Ability to exercise sound judgment.

Qualifications

• Bachelor of Science degree preferred.
• Effective written and verbal English communication skills required.
• 0-2 years’ experience in a regulated environment preferred.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Quality Assurance background preferred.
• Frequent lifting between 50-75 lbs.

Work Environment & Schedule

• Must be able to work night shift (roughly 9 PM – 9 AM, 8-hour shift).
• Work schedule: Sunday - Friday.
• Work environment: Pharmacy that 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 deemed safe by current standards.
• Facility operated under well-controlled and closely monitored conditions, regulated by State and Federal agencies.
• Specific training provided in keeping radiation exposures within regulatory guidelines.
• Routine monitoring for radiation exposure.
• Noise levels are considered low to moderate.