Senior QA Specialist – cGMP Compliance & Release

HITEC; Fort Lauderdale (FL); Sur place; USD 69 000 - 88 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

401k savings plan

Paid time off

Résumé du poste

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to review cGMP documentation, release products, and ensure compliance with 21 CFR 212. The role involves collaborating with operations and maintaining quality records in a regulated manufacturing environment.

The position is onsite in Fort Lauderdale, FL, with a night shift (1:00 am – 9:30 am) and occasional weekend work. Travel up to ~25% may be required to provide QA coverage as needed.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Quality Assurance

cGMP

English communication

ISO experience

Lifting 30-45 lbs

Formation

Bachelor's degree in science or related field

Description du poste

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to review cGMP documentation, release products, and ensure compliance with 21 CFR 212. The role involves collaborating with operations and maintaining quality records in a regulated manufacturing environment.

The position is onsite in Fort Lauderdale, FL, with a night shift (1:00 am – 9:30 am) and occasional weekend work. Travel up to ~25% may be required to provide QA coverage as needed.