Chemical/Pharmaceutical, Quality Assurance (NIGHTS)

Cardinal Health•San Antonio, TX

4d•Onsite

About The Position

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. Quality Assurance contributes to Cardinal Health by developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective. This role demonstrates knowledge of quality systems and approaches, understands relevant regulations, standards, and operating procedures, and can perform investigations/root cause analysis and develop corrective actions. The position requires an understanding of quality concepts such as cost of quality, analytical metrics and/or statistics, trending, quality planning, validation, CAPA, and problem-solving. The role involves cross-functional collaboration, interpreting requirements, and influencing others on those requirements. At this level, the role applies working knowledge of concepts, principles, and technical capabilities to perform varied tasks on projects of moderate scope and complexity, identifying and resolving technical problems using sound judgment within defined parameters. General guidance is received, with more detailed instruction on new projects, and work is reviewed for reasoning and accuracy.

Requirements

Effective written and verbal English communication skills required.
Ability to manage several tasks at the same time.
Ability to focus on tasks.
Ability to evaluate operating conditions.
Ability to exercise sound judgment.
Must be able to work night shift (roughly 9pm – 9am, with an 8-hour shift).
Must be able to work Sunday - Friday.

Nice To Haves

Bachelor's of Science degree preferred.
0-2 years’ experience in a regulated environment preferred.
Pharmaceutical or medical device experience a plus.
ISO experience a plus.
Quality Assurance background preferred.

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 products and processes as deemed necessary by the RQM.
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 upon identification.