Specialist, Quality Assurance

cardinalhealth; Mansfield (MA); On-site; USD 41,000 - 53,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

HSAs

PTO (Paid Time Off)

Disability coverage

Work-Life resources

Parental leave

Lifestyle programs

Job summary

Cardinal Health in Mansfield, MA seeks a Quality Specialist to execute QA/QC programs and minimize risks while preserving data integrity. The role reviews processes, SOPs and reports under supervision, contributing to SOP development and technical capability growth.

The position requires basic QA/QC knowledge, attention to detail, and the ability to work across teams in a fast-paced environment. Onsite work supports robust testing and regulatory readiness.

Qualifications

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

Responsibilities

• Provide Quality Control review and analyze data from pharmaceutical stability studies to ensure compliance with standards and regulatory requirements.
• Review analytical data, identify deviations or out-of-spec results, and communicate with QA leadership.
• Ensure adherence to GMP, GDP, and GLP regulations.
• Review and approve stability studies, SOPs, protocols, and other quality system documents.
• Review stability data trends, perform statistical analyses, and interpret results to assess product shelf-life.
• Support and evaluate change controls related to pharmaceutical testing.
• Stay current with industry regulations, guidelines, and best practices.
• Assist in preparation for and execution of regulatory inspections and audits.

Skills

Quality control

Quality assurance

QMS (Veeva/Agile)

LIMS (LabWare)

Attention to detail

Communication

Education

Bachelor’s degree or relevant experience

Tools

Veeva

LabWare

Job description

What Scientific Services Chemistry Center contributes to Cardinal Health

Scientific Services Chemistry Centers (SSCC) performs laboratory testing to characterize the chemistry of our medical device products and stability testing for pharmaceutical products at Cardinal Health. Under the umbrella of Quality, Regulatory and Medical Affairs (QRMA), SSCC develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterize medical devices, materials, and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. The SSCC also uses specialized instruments to perform assay and impurity/degradant tests for stability and release testing for solid dose pharmaceuticals. SSCC is a part of QRMA Scientific Services.

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

• 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.

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