Senior Specialist - Quality Assurance - Nights

Cardinal Health•Colton, CA

6d•$76,700 - $98,550•Onsite

About The Position

Cardinal Health PET Manufacturing Services manufactures PET radiopharmaceuticals to support patient treatment through improved disease diagnosis, staging, and monitoring. Quality Assurance develops and implements a compliant and cost-effective quality system to ensure products and services are reliable, safe, and effective. The role applies quality-system knowledge and relevant regulatory requirements, performs investigations and root-cause analysis, develops corrective actions, conducts gap assessments, and applies quality concepts such as metrics, trending, validation, CAPA, and problem solving. It also works cross-functionally to interpret requirements and educate and influence others. The Senior Specialist performs varied tasks using working knowledge of quality concepts and technical capabilities, works on projects of moderate scope and complexity, identifies and resolves technical problems, and exercises judgment within defined parameters. Work receives general guidance and is reviewed for sound reasoning and accuracy. The position supports CGMP documentation review and product release, including controls related to facilities and equipment, materials, laboratories, packaging and labeling, and production and processes. It establishes and reports metrics as directed by the RQM, supports compliance with 21 CFR 212, maintains documentation control, retention, and archival, collaborates with Operations on quality-system and CGMP requirements, and escalates quality-system issues and discrepancies to the regional RQM. This is a night-shift role in Denver, Colorado, with hours beginning at midnight or 1 a.m. Monday through Friday. The primary work environment is a pharmacy maintained in clean, orderly, well-lit, and optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation deemed safe by current standards. The facility operates under closely monitored conditions regulated by state and federal agencies; employees receive radiation-safety training and routine exposure monitoring. Noise levels are low to moderate. Frequent lifting of 50–75 pounds is required, along with the ability to manage multiple tasks, focus, evaluate operating conditions, and exercise sound judgment.

Requirements

Must be able to work nights, with hours starting at midnight or 1 a.m. Monday through Friday.
Effective written and verbal English communication skills.
Ability to manage several tasks at the same time, focus on tasks, evaluate operating conditions, and exercise sound judgment.
Frequent lifting of 50–75 pounds.

Nice To Haves

Bachelor of Science degree in Chemistry or Biology preferred.
One to two years of experience in Quality Assurance and/or a regulated environment, preferably cGMP.
Pharmaceutical or medical device experience.
ISO experience.
Quality Assurance background.

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 RQM.
Ensure the site manufactures products in compliance with 21 CFR 212 CGMP requirements.
Control, retain, and archive documentation supporting CGMP activities.
Collaborate with the Operations department to drive quality-system and CGMP requirements.
Perform product-release activities according to CGMP requirements.
Report quality-system issues to the regional RQM and promptly escalate discrepancies when identified.
Apply quality concepts and technical capabilities to varied tasks and projects of moderate scope and complexity.
Identify possible solutions to technical problems and take action to resolve them.