Senior QA Specialist – Night Shift, cGMP PET Manufacturing

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

HSA

FSAs

Disability coverage

Parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Dallas, TX is seeking a Quality Assurance professional to support cGMP manufacturing and documentation controls. The role focuses on ensuring product release quality, regulatory compliance and collaborative interactions with operations to uphold quality standards.

The position requires 2+ years in related science and 1-2 years in QA/cGMP environments, with strong English communication and the ability to lift up to 45 lbs. Onsite with periodic travel and night shift options.

Qualifications

• Bachelor’s degree or equivalent work experience preferred.
• 2+ years in a related science field preferred.
• 1-2 years in Quality Assurance and/or cGMP environment preferred.
• Pharmaceutical or medical device experience a plus.

Responsibilities

• Review cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related to products and processes as directed by the Regional Quality Manager.
• Ensure site manufactures products to meet 21 CFR 212 (cGMP) requirements.
• Manage and archive quality documentation to support cGMP activities.
• Collaborate with operations to drive quality system and cGMP compliance.
• Perform product release activities per cGMP requirements.
• Escalate quality system issues and discrepancies promptly.

Skills

-English communication

2+ years related science experience

1-2 years QA/cGMP experience

Physical lifting ability

Education

Bachelor’s degree in related field or equivalent

Job description

Cardinal Health in Dallas, TX is seeking a Quality Assurance professional to support cGMP manufacturing and documentation controls. The role focuses on ensuring product release quality, regulatory compliance and collaborative interactions with operations to uphold quality standards.

The position requires 2+ years in related science and 1-2 years in QA/cGMP environments, with strong English communication and the ability to lift up to 45 lbs. Onsite with periodic travel and night shift options.