QA Specialist, CGMP & Product Release

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health PET Manufacturing Services in Texas is seeking a Quality Assurance professional to ensure CGMP compliance, perform documentation reviews, and support product release across facilities and processes.

You will establish metrics, collaborate with operations, and help maintain quality systems while working a night shift Sunday through Friday. This role requires a bachelor’s degree, 0–2 years in a regulated environment, and strong English communication.

Qualifications

• Bachelor's of Science degree preferred.
• Effective written and verbal English communication skills required.
• 0-2 years’ experience in a regulated environment preferred.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Quality Assurance background preferred.
• Lifting: Frequent lifting between 50-75 lbs.
• Must be able to work night shift: roughly 9pm–9am (Sunday - Friday).

Responsibilities

• Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establish and report metrics related products and processes as deemed necessary by the RQM.
• Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities.
• Engage and collaboration with operations department to drive quality system and CGMP requirements.
• Responsible for product release activities per CGMP requirements.
• Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification.

Skills

Quality systems

Regulatory knowledge

Root cause analysis

Gap assessment

Quality metrics

Cross-functional

Education

Bachelor's degree

Job description

Cardinal Health PET Manufacturing Services in Texas is seeking a Quality Assurance professional to ensure CGMP compliance, perform documentation reviews, and support product release across facilities and processes.

You will establish metrics, collaborate with operations, and help maintain quality systems while working a night shift Sunday through Friday. This role requires a bachelor’s degree, 0–2 years in a regulated environment, and strong English communication.