Sr. Specialist, Quality Assurance

Cardinal Health•Fort Lauderdale, FL

7d•$68,500 - $88,020•Onsite

About The Position

Cardinal Health Positron Emission Tomography (PET) Manufacturing Services manufactures PET radiopharmaceuticals to support improved disease diagnosis, staging, and monitoring. Quality Assurance develops and implements a compliant and cost-effective quality system to help ensure products and services are reliable, safe, effective, and compliant with regulatory standards and specifications. The role provides oversight of manufacturing activities, supports quality documentation and release processes, and collaborates with operational teams on quality-system and cGMP requirements. This is an onsite, 40-hour-per-week night position in Fort Lauderdale, Florida. The typical schedule is Monday through Friday, 1:00 a.m. to 9:30 a.m., with a few hours of work on every other Saturday. The employee must be flexible to work different shifts or schedules based on business needs and may need to stay until daily work is completed. Work hours may change. The position may require approximately 25% travel to provide QA coverage when needed. The primary work environment is a clean, orderly, well-maintained manufacturing pharmacy. Employees handle radioactive materials and are exposed to very low amounts of radiation considered safe by current standards. The facility operates under closely monitored State and Federal regulations, and employees receive training and routine monitoring to keep radiation exposure within regulatory guidelines. Noise levels are low to moderate.

Requirements

Bachelor’s degree in a related science field, or equivalent work experience; listed as preferred.
At least 2 years of experience in a related science field; listed as preferred.
1–2 years of experience in Quality Assurance and/or a cGMP-regulated environment; highly preferred.
Effective written and verbal English communication skills.
Ability to lift up to 30–45 lbs.
Flexibility to work different shifts or schedules based on business needs and stay until work is completed each business day.
Comfort working with radioactive materials under radiation-safety training and monitoring.

Nice To Haves

Pharmaceutical or medical device experience.
ISO experience.

Responsibilities

Review cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
Establish and report metrics related to products and processes as deemed necessary by the Regional Quality Manager (RQM).
Ensure the site manufactures products in accordance with 21 CFR 212 cGMP requirements.
Manage and ensure the quality of documentation, including its control, retention, and archival, to support cGMP activities.
Collaborate with the operations department to advance quality-system and cGMP requirements.
Perform product release activities in accordance with cGMP requirements.
Report quality-system issues to the RQM and others as necessary, including timely escalation of discrepancies when identified.