Sr. Specialist, Quality Assurance

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 ability to review and disposition documentation in a timely manner, such as: manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc.
• Demonstrates proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
• Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
• Demonstrates ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner.
• 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.

Production Responsibilities

• Must have experience performing quality control testing on product samples.
• Must be willing to train and qualify on GE products.
• Work in partnership with cross functional teams to ensure product/production
  expectations and demands are met.
• Flexibility to work periodic production hours in support of routine production and testing needs, expectations could be up to 30% depending on production needs.
• Must maintain proficiency on production qualifications. 

Schedule:  40 hours per week.  This is a night position.  Typically, Monday - Friday 1:30 am - 9:30 am.  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.

Responsiblities

• 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.
• Monitors CAPA in investigations and closes when completed or escalates (if necessary).
• Performs aseptic review of the site with operations and documents results.
• 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 Quality Assurance and/or regulated environment high