Specialist, Quality Assurance

Cardinal Health; United States; On-site; USD 41,000 - 53,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time-off

401k savings plan

Health savings account (HSA)

Job summary

Cardinal Health’s Scientific Services Chemistry Center in Mansfield, MA seeks a Quality Specialist to execute quality programs and support GMP/GDP/GLP compliant stability testing. The role involves reviewing data, ensuring compliance, and assisting with regulatory inspections, under QA leadership.

The position emphasizes cross-functional collaboration, attention to detail, and timely documentation within a fast-paced pharmaceutical testing environment.

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.

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.

Skills

Quality assurance concepts

Attention to detail

Communication skills

Cross-functional collaboration

Prioritization

Education

BSc in chemistry/pharmacy or related field

Relevant work experience

Tools

Veeva/Agile

LIMS (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

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.

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.