Senior QA Specialist: cGMP & Documentation (Night Shift)

Cardinal Health; Dallas (TX); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

HSA

Job summary

Cardinal Health is seeking a Quality Assurance professional to support PET manufacturing operations in Dallas, TX. The role involves reviewing cGMP documentation, ensuring regulatory compliance, and driving quality across production processes.

The position features a night shift with potential weekend work and up to ~25% travel for QA coverage. Candidates should have a related bachelor’s degree and 2+ years in QA or cGMP environments; pharmaceutical or medical device experience is a plus.

Qualifications

• Bachelor’s degree in related field preferred or equivalent work experience.
• 2+ years of experience in QA and/or cGMP environment preferred.
• Pharmaceutical or medical device experience a plus.
• Effective written and verbal English communication skills.

Responsibilities

• Review cGMP documentation related to product release, facilities, equipment, and controls.
• Establish and report quality metrics as directed by the RQM.
• Ensure site products meet 21 CFR 212 (cGMP) requirements.
• Manage documentation control and archival for cGMP activities.
• Collaborate with operations to drive quality system compliance.
• Perform product release activities per cGMP requirements.
• Escalate quality system issues to the RQM as needed.

Skills

Attention to detail

cGMP knowledge

English communication

Problem solving

Education

Bachelor’s degree or equivalent

Job description

Cardinal Health is seeking a Quality Assurance professional to support PET manufacturing operations in Dallas, TX. The role involves reviewing cGMP documentation, ensuring regulatory compliance, and driving quality across production processes.

The position features a night shift with potential weekend work and up to ~25% travel for QA coverage. Candidates should have a related bachelor’s degree and 2+ years in QA or cGMP environments; pharmaceutical or medical device experience is a plus.