Quality Assurance (QA) Specialist II

Weil Group • Barceloneta, PR

2d

About The Position

We are seeking a professional qualified to assure the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices). The Quality Associate supports the Global Biologics Quality Function within Operations. Expectations that the Quality Associate III will maintain high quality levels on all aspects of their job, while achieving high levels of efficiency.

Requirements

• Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 4+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with Client Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written .
• Change and investigation documentation
• Bachelor’s Degree in Science or Eng
• +4 years of experience in Quality area position
• BS degree or 3-5 years equivalent experience.

Nice To Haves

• Bilingual
• if possible, experience with project management

Responsibilities

• Responsible for various aspects of the product’s quality assurance related to their functional area.
• Ensures that product is consistently manufactured in conformance with AbbVie’s Quality System requirements and all applicable regulatory requirements throughout the network, including third party manufacturers.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with management for Quality Initiatives, Projects, Product Transfers, etc.
• Incumbent is responsible for ensuring compliance with AbbVie’s Quality Systems and cGMPs.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level