Quality Assurance Specialist: Stability & Compliance

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

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.