Senior QA Specialist — cGMP Quality Lead (Night Shift)

Cardinal Health; Fort Lauderdale (FL); 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

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Job summary

Cardinal Health in Fort Lauderdale, FL seeks a Quality Assurance professional to review cGMP documentation, support product release, and ensure regulatory compliance across facilities and processes. The role requires collaboration with operations to drive the quality system and timely escalation of discrepancies.

The position supports a manufacturing pharmacy environment handling radiopharmaceuticals, with night shifts and potential travel for QA coverage.

Qualifications

• Bachelor’s degree in related field (science) preferred, or equivalent work experience preferred.
• 2+ years of experience in related science field preferred.
• 1-2 years of experience in Quality Assurance and/or cGMP regulated environment highly 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

QA documentation

cGMP knowledge

Regulatory compliance

Collaboration with operations

Physical stamina

Education

Bachelor's degree in science

Equivalent work experience

Job description

Cardinal Health in Fort Lauderdale, FL seeks a Quality Assurance professional to review cGMP documentation, support product release, and ensure regulatory compliance across facilities and processes. The role requires collaboration with operations to drive the quality system and timely escalation of discrepancies.

The position supports a manufacturing pharmacy environment handling radiopharmaceuticals, with night shifts and potential travel for QA coverage.