Sr. Specialist, Quality Assurance

Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines

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 an understanding of the requirements and has the ability to perform gap assessments to those requirements.
  • 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.

What Specialist, Quality Assurance contributes to Cardinal Health

  • Reports to Director, QRA Management
  • QA Specialist is responsible for ensuring quality standards and procedures are followed. Inspection and quality assurance activities to meet specifications and quality standards for variety of manufacturing products.

Accountabilities

  • 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.
  • 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.
  • Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
  • Ability to network across business and functional units to achieve positive outcomes.
  • Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
  • 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.

Performance Expectations

  • Models the characteristics outlined in the Cardinal Health Leadership Essentials - Professional and Business Support.
  • Demonstrates a commitment to the organization’s mission, vision, and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
  • Works as part of a team with others and shows respect and values diversity toward others.
  • Demonstrates efforts to discovering, meeting, and advocating for the customer’s needs.
  • Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
  • Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including, but not limited to, maintaining required trainings as appropriate to position requirements.
  • The ability to act calmly and patiently when working under pressure and/or conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity, and promotes alternative perspectives.

Qualifications

  • Bachelor’s of Science preferred – Chemistry degree highly preferred or equivalent work experience, preferred
  • 2+ years’ experience in a regulated environment, pharmaceutical experience preferred.
  • Possess an understanding of cGMP/compliance requirements for 210/211.
  • Attention to detail.
  • Ability to manage timelines and priorities.
  • Ability to work independently with minimum guidance.
  • Ability to multi-task.

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

Anticipated Pay Range: 55,200.00 - 91,700.00

Bonus Eligible:  No

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD, etc.

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.