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.

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 and process controls.
• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.
• Establish and report metrics related products and processes.
• Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting requirements.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Ensures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the cGMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Schedule

• Onsite in Aurora, CO. Typically, Monday-Friday between 8:00 am-5:00 pm.
• Candidate must be available to work holidays and weekends to provide coverage at site as needed. Weekend work will be limited.

Qualifications

• Bachelor's degree in related field, or equivalent work experience, preferred
• 2+ years of experience in a regulated environment preferred. Pharmaceutical experience preferred.
• Possess an understanding of cGMP/compliance requirements preferred, 21 CFR 210 and 211 preferred.
• Strong attention to detail.
• Ability to manage timelines and priorities.
• Ability to multi-task.
• Ability to work independently with minimum guidance.

Physical/ Mental Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds.

Work Environment

• The primary work environment consists of an office, warehouse, and production environments within a radiopharmaceutical manufacturing facility. 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 groups. 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-$108,000

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:01/11/2025 *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.