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

• This position will serve as the primary Quality Assurance representative for production line and laboratory operations.
• Support the production and laboratory operations by being a QA presence on the shop floor; conduct real-time documentation reviews, ensure compliance to site procedures and regulations, and provide guidance where appropriate.
• Quality Assurance responsibilities include but are not limited to cGMP documentation review related to product release, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Responsible for the quality of documentation (control, retention, and archival) to support material release.
• Maintain accurate and current quality records.
• Performs real-time QA review of batch documentation and other GMP related documents.
• Issuance and reconciliation of product labels for production.
• Perform Acceptable Quality limit (AQL) testing for visual inspection.
• Understands technical/release product issues and evaluate their potential impact on product quality and compliance.
• Ability to network across business and functional units to achieve positive outcomes.
• Engage and collaboration with operations department to drive quality system and cGMP requirements.
• Assist Quality Management with Regulatory Body Inspections.
• Performs other duties as assigned.

Qualifications

• Bachelor of Science degree preferred or equivalent work experience preferred
• 2 years of relevant work experience in GMP and/or FDA regulated industry (Pharmaceutical or Medical Device) preferred
• Must work well with others and understand how to be successful in a team environment.
• Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
• Ability to work independently with minimum guidance
• ISO experience a plus
• Quality Assurance background preferred

Location

• Onsite in Indianapolis, IN

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. 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:$66,500-$95,000

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: 05/26/2024 *if interested in opportunity, please submit application as soon as possible.

Indianapolis Metro Area

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.