Jobs

Description

Purpose:

• The Quality Associate supports the Global Biologics Quality Function within Operations.
• The expectation is 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 Quality Assurance oversight of biologic products throughout the product lifecycle, ensuring compliance with cGMPs, regulatory requirements, and Client Quality Systems.
• Support quality-related activities including product transfers, quality initiatives, continuous improvement projects, and cross-functional business objectives.
• Manage and support change control records, including impact assessments, implementation activities, documentation, and effectiveness verification.
• Perform documentation, batch record, and data reviews, ensuring compliance with ALCOA+ data integrity principles and Good Documentation Practices.
• Oversee document management processes, including creation, review, approval, revision control, and archival of controlled quality documents.
• General knowledge in quality and business systems including SAP, OneTrack, TrackWise, OneVault, and other electronic quality management systems to support compliant operations.
• Communicate and collaborate effectively with management and cross-functional stakeholders regarding Quality initiatives, manufacturing activities, regulatory commitments, and business-critical projects.
• Ensure ongoing compliance with Client Quality Systems, cGMP regulations, regulatory expectations, and company policies while supporting inspection and audit readiness.

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
• 2+ 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 be familiar with 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
• +2 years of experience in Quality area position
• if possible, experience with project management
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-5 years equivalent experience..

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
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• BS degree or 3-5 years equivalent experience.

Experience Level = 3 to 5 Years