QA Specialist — cGMP & PET Manufacturing (Night Shift)

Regulatory Jobs; 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

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 for a night-shift role in Fort Lauderdale, FL. The position focuses on cGMP documentation review, product release, and quality system oversight within a PET manufacturing environment.

The role involves collaboration with operations, documentation control, and adherence to 21 CFR 212. Candidates should have 2+ years in related science fields and 1–2 years in QA/cGMP settings, with English communication skills and ISO exposure as pluses.

Qualifications

• Bachelor’s degree in science or related field preferred.
• 2+ years in related science field preferred.
• 1-2 years of QA experience in a cGMP environment preferred.
• Pharmaceutical or medical device experience a plus.
• Strong written and verbal English communication skills.
• ISO experience a plus.
• Ability to lift 30-45 lbs.

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.
• Ensure site manufactures products to meet the requirements of 21 CFR 212 (cGMP).
• Handle and ensure quality of documentation (control, retention, and archival) to support cGMP activities.
• Engage and collaborate with operations to drive quality system and cGMP requirements.
• Perform product release activities per cGMP requirements.
• Report quality system issues to the RQM and others as necessary, with timely escalation of discrepancies.

Skills

QA experience

cGMP knowledge

English communication

ISO experience

Lifting up to 45 lbs

Education

Bachelor’s degree in science or equivalent

Job description

Cardinal Health is seeking a Quality Assurance professional for a night-shift role in Fort Lauderdale, FL. The position focuses on cGMP documentation review, product release, and quality system oversight within a PET manufacturing environment.

The role involves collaboration with operations, documentation control, and adherence to 21 CFR 212. Candidates should have 2+ years in related science fields and 1–2 years in QA/cGMP settings, with English communication skills and ISO exposure as pluses.