Sr. Specialist, Quality Assurance

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 67,000 - 95,000; Full time

Job summary

An established industry player is seeking a Quality Assurance professional to ensure compliance and safety in a dynamic environment. This role involves developing quality systems, conducting investigations, and maintaining documentation to uphold high standards of product quality. You'll collaborate across teams to influence and educate on quality requirements while championing compliance and safety practices. Join a company that values your contributions and offers a supportive workplace where your skills can shine. If you're passionate about quality and eager to make a difference, this opportunity is perfect for you.

Benefits

Medical, dental, and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before payday

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Qualifications

• Bachelor's in a science-related field preferred.
• 2+ years’ experience in a related field preferred.

Responsibilities

• Maintains accurate and current Quality records.
• Performs real-time QA review of batch documentation.

Skills

Quality Systems Knowledge

Root Cause Analysis

Regulatory Compliance

Analytical Metrics

Problem-Solving

Communication Skills

Attention to Detail

Education

Bachelor's in Science-related Field

Equivalent Work Experience

Tools

Microsoft Office Suite

Adobe Editing Software

Document Management Software

Job description

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.

Responsibilities

• Maintains 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 AQL testing for visual inspection.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Champion Quality, GMP compliance, and EHS/Radiation Safety practices.
• Ability to network across business and functional units to achieve positive outcomes.
• Assists Quality Management with FDA and other regulatory agency activities.
• Demonstrates efforts to discover, meet, and advocate 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.
• Demonstrated 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.
• Performs other job duties as assigned.

Qualifications

• Bachelor's in a science-related field (processing engineering, Chemistry, Biology) or equivalent work experience preferred.
• 2+ years’ experience in a related field preferred.
• 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
• Possess an understanding of cGMP/compliance requirements for cosmetic and pharmaceutical products.
• Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred.
• Working knowledge of Adobe editing software strongly preferred.
• Working knowledge of Document Management software (Trackwise and/or Smartsolve) strongly preferred.
• Demonstrated ability to manage timelines and priorities.
• Demonstrated ability to work independently with minimum guidance.
• Demonstrated ability to multi-task and focus attention to detail.
• 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.

A Covid-19 vaccination is required in order to be employed in this position. This includes either:

• 2 doses of the Moderna or Pfizer vaccine.
• 1 dose of the Johnson & Johnson vaccine.
• Please Note: vaccines may be required for the position subject to federal, state, and/or customer requirements.

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 and may receive more detailed instruction on new projects.
• Work reviewed for sound reasoning and accuracy.

Work Environment

• The primary work environment consists of a radiopharmaceutical manufacturing facility.
• Employees may handle radioactive materials and may be 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 enforced by the corporate internal quality and regulatory group.
• Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and will be routinely monitored for their exposure to radiation.
• Noise levels are considered low to moderate.

Anticipated salary range: $67,500 - $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 payday 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: 4/18/2025. *If interested in the 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 candidate’s 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.