Principal Specialist, Quality Assurance (Contract Manufacturing)

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

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

Responsibilities

• Supports an effective Sponsor training program.
• Ensures Sponsor documentation is current, controlled, and made available to applicable site personnel.
• Provides advice, guidance and training to PET personnel on various documents and change controls.
• Interacts with Sponsors and Project Managers to ensure needs are met.
• Develops and implements procedures/protocols for training, document control, and change control as it relates to the Sponsor.
• Ensures PET manufacturing sites have adequate supply of approved labels/labeling to meet manufacturing schedules.
• Evaluates all document change requests to determine any potential Sponsor impact.
• Supports the technology transfer of Sponsor drug products to Cardinal Health by leveraging compliance, quality, and training to ensure smooth transitions.
• Collaborates with others in order to meet deadlines and stay compliant per Sponsor NDA’s/IND’s.
• Interacts with regulatory agencies, and/or sponsor visits as necessary.
• Identifies opportunities to improve efficiency.
• Ensures that Sponsors have a positive experience; commits to meet or exceed expectations.

Qualifications

• Bachelors in related field, or equivalent work experience, preferred
• 4+ year's experience in related field, preferred
• Experience working with Contract Manufacturers (CMO)
• PET Quality Experience, preferred
• Understanding of Quality Agreements, preferred
• 50% travel required
• Must be flexible with travel, may include short notice

Location

• Remote
• Must be able to travel up to 50% of the time

Work Environment

• 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 employee will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• May contribute to the development of policies and procedures
• Works on complex projects of large scope
• Develops technical solutions to a wide range of difficult problems
• Solutions are innovative and consistent with organization objectives
• Completes work; independently receives general guidance on new projects
• Work reviewed for purpose of meeting objectives
• May act as a mentor to less experienced colleagues

Anticipated salary range: $79,700-$113,800

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 12/09/2024 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. P