Quality Assurance (QA) Specialist

Description

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

• 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.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Responsible for various aspects of the product’s quality assurance related to their functional area.
• Ensures that product is consistently manufactured in conformance with Client’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 Client’s Quality Systems and cGMPs.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• 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

What are the top 3-5 skills, experience or education required for this position:

• Change and investigation documentation
• Bilingual
• Bachelor’s Degree in Science or Eng
• +4 years of experience in Quality area position
• if possible, experience with project management

Experience Level = 3 to 5 Years