Title: Quality Assurance (QA) Specialist II
Duration: 06+ Months
Location: Barceloneta PR (Hybrid)
Pay Range: $27/hr - $32.25/hr
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:
Responsible for Quality Assurance oversight of biologic products throughout the product lifecycle, ensuring compliance with cGMPs, regulatory requirements, and 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 Quality Systems, cGMP regulations, regulatory expectations, and company policies while supporting inspection and audit readiness.
Qualifications:
•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
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:
1. Change and investigation documentation
2.Bilingual
3. Bachelor’s Degree in Science or Eng
4. +4 years of experience in Quality area position
5. if possible, experience with project management