Sr. Specialist, Quality Assurance

Cardinal Health•Fort Lauderdale, FL

6d•Onsite

About The Position

Quality Assurance develops and implements policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. The function establishes compliant and cost-effective quality systems that ensure products and services are reliable, safe, and effective, and provides oversight of manufacturing activities, training, and guidance on quality policies and procedures. Cardinal Health PET Manufacturing Services manufactures PET radiopharmaceuticals to support patient treatment through improved disease diagnosis, staging, and monitoring. This role supports quality assurance for PET manufacturing, including cGMP documentation review, product release, quality-system activities, and collaboration with operations. The position is onsite in Fort Lauderdale, Florida, for 40 hours per week. It is a night position, typically Monday through Friday from 1:00 a.m. to 9:30 a.m., with a few hours of work on every other Saturday. The schedule may change based on business needs, and the employee must be flexible to work different shifts, stay until work is completed, and travel approximately 25% when QA coverage is needed. The primary work environment is a manufacturing pharmacy that must be kept clean, orderly, properly lighted, and in optimum operating condition. Employees handle radioactive materials and may be exposed to very low amounts of radiation deemed safe under current standards. The facility operates under controlled and monitored conditions regulated by State and Federal agencies. Staff receive radiation-safety training and are routinely monitored for exposure. Noise levels are low to moderate.

Requirements

Bachelor’s degree in a related field, such as science, or equivalent work experience; listed as preferred.
Two or more years of experience in a related science field; listed as preferred.
One to two 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 pounds.
Flexibility to work different shifts or schedules based on business needs and to stay until work is completed each business day.
Ability to travel approximately 25% when needed for QA coverage.

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 determined necessary by the Regional Quality Manager (RQM).
Ensure the site manufactures products in accordance with 21 CFR 212 cGMP requirements.
Control, retain, and archive documentation supporting 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, and promptly escalate discrepancies when identified.
Apply working knowledge of concepts, principles, and technical capabilities to varied tasks; work on moderately scoped projects; identify and resolve technical problems; and exercise judgment within defined parameters.