Senior Specialist, Quality Assurance

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

• Performs all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility.
• 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.

Schedule

• Onsite in Roseville, MN.
• Rotating schedule. Shifts are Monday-Friday from either 12:00 am-8:30 am or 3:30 am- 12:00 pm. Some weekend work may be required. Weekend shift is typically a few hours. 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 degree in related field, or equivalent work experience, preferred
• 2-4 years of experience, preferred
• Some travel may be required
• Proficiency with MS Excel and MS Word
• Effective written and verbal English communication skills
• Strong attention to detail
• Ability to lift between 30-45 lbs.
• Pharmaceutical or medical device experience a plus
• ISO experience a plus

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 he/she 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 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 action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range:$75,600-$106,400

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:1/20/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.