Senior Quality Assurance Specialist

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

The primary work environment consists of a manufacturing 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 levels are considered low to moderate.

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.

Schedule:  40 hours per week.  This is a night position.  Typically an 8-10 hour shift starting at 12 am (midnight). 1 to 2 weekends per month and holidays.  Candidate must be flexible based on business need.


Accountabilities

  • Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
  • Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
  • Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)
  • Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities
  • Engages and collaborates with operations department to drive quality system and CGMP requirements
  • Performs product release activities per CGMP requirements
  • Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.
     

Qualifications

  • Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred
  • 2+ years of experience in related science field preferred
  • 1-2 years of experience in QA and/or regulated environment highly preferred – cGMP
  • Pharmaceutical or medical device experience a plus
  • Effective written and verbal English communication skills
  • ISO experience a plus
  • Quality Assurance background preferred
  • Ability to lift  between 50-75 lbs

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
  • 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

e.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.