Senior Specialist, Quality Assurance (Nights)

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.

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

Responsibilities

• 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 Regional Quality Manager
• 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 Quality Manager. This includes timely escalation of discrepancies upon identification

Location/Schedule

• Must be able to work nights

• Onsite role in Van Nuys, CA. 40 hours per week. Typically, Monday through Friday, starting at either midnight or 1:00 AM and every other Saturday

• Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day.  Work hours may be subject to change.

Qualifications

• Bachelor's of Science in Chemistry or Biology degree preferred
• 1-2 years experience in QA and/or regulated environment highly preferred (cGMP)
• Effective written and verbal English communication skills required
• Pharmaceutical or medical device experience a plus
• ISO 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

What is expected of you and others at this level

• 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

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 material