Senior Specialist - Quality Assurance - Nights

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

What Quality Assurance contributes to Cardinal Health:

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.

Demonstrates knowledge of quality systems and approaches.

Demonstrates an understanding of the relevant regulations, standards and operating procedures.

Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.

Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.

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 the requirements as well as educate and influence others on those requirements.

Responsibilities:

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

Applies judgment within defined parameters

Receives general guidance; may receive more detailed instruction on new projects

Work reviewed for sound reasoning and accuracy

Accountabilities:

Quality Assurance responsibilities include but are not limited to 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 collaboration with 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. This includes timely escalation of discrepancies upon identification.

Qualifications:

Must be able to work NIGHTS Hours can start at midnight or 1am M-F located in Denver, COBachelor's of Science in Chemistry or Biology degree preferred

Effective written and verbal English communication skills required1-2 years experience in QA and/or regulated environment highly preferred - cGMPPharmaceutical or medical device experience a plusISO experience a plus Quality Assurance background preferred

Lifting:
Frequent lifting between 50-75 lbs Ability to manage several tasks at the same time;
Ability to focus on tasks ;
Ability to evaluate operating conditions ;
Ability to exercise sound judgment Personal Protective Equipment Work Environment:

The primary work environment consists of a pharmacy which 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 that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group.

Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise…