Specialist, Quality Assurance

Cardinal Health, Inc.; Mansfield (MA); On-site; USD 41,000 - 53,000; Full time

Job summary

Cardinal Health, Inc. is seeking a Quality Specialist for its onsite Scientific Services Chemistry Center in Mansfield, MA. You will execute quality programs to minimize risk and ensure data integrity, reviewing processes and SOPs while collaborating with senior staff.

The role requires a basic QA/QC foundation, 0–2 years of pharma QC experience, and familiarity with systems like Veeva/LIMS. Excellent attention to detail and cross-functional collaboration are essential for success.

Qualifications

• Bachelor’s degree preferred or equivalent work experience.
• 0–2 years of quality control in pharma/biopharma preferred.
• Basic QA/QC concepts knowledge.
• Experience with QA systems and LIMS is a plus.

Responsibilities

• Provide Quality Control review and analyze data from stability studies.
• Review data deviations and communicate with QA leadership.
• Ensure GMP, GDP, and GLP compliance.
• Review and approve stability studies, SOPs, and protocols.
• Review stability data trends and interpret product shelf-life.

Skills

Quality concepts

Attention to detail

Communication skills

Cross-functional teamwork

Education

Bachelor’s degree in chemistry or related field

Tools

Veeva

Agile

LabWare

Job description

What Scientific Services Chemistry Center contributes to Cardinal Health

This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.

Job Summary

The Quality Specialist executes quality programs, policies, and procedures in a particular area of specialty to minimize risks and drive data integrity. With basic knowledge of quality assurance and quality control concepts, the Specialist reviews processes and documents and contributes to the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities.

Responsibilities

• Provide Quality Control review and analyze data from pharmaceutical stability studies to ensure compliance with established quality standards and regulatory requirements.
• Thoroughly review analytical data generated from analyses, identifying any deviations or out-of-specification results, and communicating directly with Quality Assurance (QA) leadership.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) regulations.
• Perform review and approve stability studies, SOPs, protocols, and other relevant quality system documentation to ensure accuracy and compliance.
• Review stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life.
• Support and evaluate change controls related to pharmaceutical testing.
• Stay current with industry regulations, guidelines, and best practices.
• Assist in the preparation for and execution of regulatory inspections and audits.

Qualifications

• Bachelor’s degree in chemistry, pharmacy or a related scientific field, preferred, or relevant work experience.
• 0-2 years of experience in quality control within a pharmaceutical or biopharmaceutical manufacturing or testing environment, preferred.
• Basic knowledge of quality assurance and quality control concepts.
• Experience with quality management systems (e.g., Veeva, Agile), experience with LIMS (e.g., LabWare) is a plus.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility.
• Excellent attention to detail.
• Strong communication (both oral and written) and reporting skills.
• Ability to work in a fast-paced, cross-functional environment.

What is expected of you and others at this level

• Apply basic concepts, principles and technical capabilities to perform routine tasks.
• Works on projects of limited scope and complexity.
• Follows established procedures to resolve readily identifiable technical problems.
• Works under direct supervision and receives detailed instructions.
• Develops competence by performing structured work assignments.
• Demonstrated initiative – able to work proactively with direct supervision and with a continuous improvement mind-set.

Anticipated hourly range:$30.10 per hour - $38.61 per hour

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and wellbeing.

• 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:09/21/2026

The hourly 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.

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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.