Onsite Quality Assurance Specialist – Pharma Stability

Cardinal Health; Mansfield, Northern (MA, KY); Hybrid; USD 41,000 - 52,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k

MyFlexPay

FSAs

Disability insurance

Work-life resources

Parental leave

Wellness programs

Job summary

Cardinal Health's Scientific Services Chemistry Center in Mansfield, MA seeks a Quality Specialist to support QA/QC programs and data integrity for medical devices and pharmaceuticals. You will review stability data, SOPs, and change controls under supervision to ensure compliance with GMP, GDP and GLP.

Ideal candidates have a chemistry-related degree and up to 2 years in pharma QC; you should demonstrate attention to detail, clear communication, and the ability to work in a fast-paced

Qualifications

• Bachelor’s degree in chemistry, pharmacy or related field, preferred, or relevant work experience.
• 0-2 years of experience in quality control within a pharmaceutical or biopharmaceutical environment.
• Basic knowledge of quality assurance and quality control concepts.
• Experience with quality management systems (e.g., Veeva, Agile), LIMS (e.g., LabWare) is a plus.
• Ability to prioritize objectives from multiple projects and meet deadlines.
• Excellent attention to detail.
• Strong communication 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 standards.
• Review analytical data, identify deviations, and communicate with QA leadership.
• Ensure adherence to GMP, GDP, and GLP regulations.
• Review and approve stability studies, SOPs, protocols, and related quality documents.
• Review stability data trends and interpret degradation to assess shelf-life.
• Support and evaluate changes related to pharmaceutical testing.
• Stay current with industry regulations and best practices.
• Assist in regulatory inspections and audits preparation.

Skills

Basic QA concepts

Strong communication

Attention to detail

Cross-functional work

Education

Bachelor’s degree in chemistry / pharmacy / related field

Tools

Quality management systems (Veeva, Agile)

LIMS (LabWare)

Job description

Cardinal Health's Scientific Services Chemistry Center in Mansfield, MA seeks a Quality Specialist to support QA/QC programs and data integrity for medical devices and pharmaceuticals. You will review stability data, SOPs, and change controls under supervision to ensure compliance with GMP, GDP and GLP.

Ideal candidates have a chemistry-related degree and up to 2 years in pharma QC; you should demonstrate attention to detail, clear communication, and the ability to work in a fast-paced