QA Specialist, cGMP & PET Manufacturing (Night Shift)

Regulatory Jobs; Dallas (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)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Quality Assurance professional to support cGMP documentation, product release, and QA oversight in a manufacturing pharmacy environment in Dallas, TX. This night shift role requires flexibility and occasional travel.

The incumbent will ensure adherence to regulatory standards, establish quality metrics, and work with operations to sustain a compliant quality system. 40 hours weekly, onsite.

Qualifications

• Bachelor’s degree in related field or equivalent work experience.
• 2+ years of experience in related science field preferred.
• 1-2 years of experience in Quality Assurance and/or cGMP regulated environment preferred.
• Pharmaceutical or medical device experience a plus.
• Effective written and verbal English communication skills.
• ISO experience a plus.
• Ability to lift up to 30-45 lbs.

Responsibilities

• Handles cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM).
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (cGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support cGMP activities.
• Engages and collaborates with operations department to drive quality system and cGMP requirements.
• Performs product release activities per cGMP requirements.
• Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Skills

English communication

Lifting 30-45 lbs

ISO experience

Education

Bachelor’s degree or equivalent

Job description

Cardinal Health is seeking a Quality Assurance professional to support cGMP documentation, product release, and QA oversight in a manufacturing pharmacy environment in Dallas, TX. This night shift role requires flexibility and occasional travel.

The incumbent will ensure adherence to regulatory standards, establish quality metrics, and work with operations to sustain a compliant quality system. 40 hours weekly, onsite.