Quality Operations Specialist – Pharma/Biotech

About the role

The Quality Operations Specialist supports site management in overseeing the execution of the quality system across manufacturing and production areas. You will monitor, document, discuss and report quality events to ensure that all released batches meet the highest standards of quality and compliance.

Key responsibilities

• Ensure products are manufactured in accordance with approved company policies, processes and procedures.
• Provide quality oversight for GMP manufacturing, technical operations, engineering, QC laboratory and supply‑chain activities.
• Review incoming material inspection packages, batch records, manufacturing logs and changeover activities; manage QA holds and tags.
• Release incoming material, process and product batches after appropriate review.
• Participate in investigations of non‑compliance in materials, testing, manufacturing, warehousing and product.
• Support change management as a change coordinator or QA overseer to ensure compliance with policies.
• Conduct regular walk‑throughs of manufacturing, engineering, warehouse and QC areas to maintain compliance.
• Assist with new product introductions, operational excellence projects and other tasks assigned by management.

Required profile

• Bachelor’s degree in a natural science, engineering, pharmacy or related field.
• Minimum 2 years of experience in a pharmaceutical/biopharmaceutical quality or compliance (GxP) environment.
• Ability to quickly understand products and processes to assess quality issues.
• Strong integrity, work ethic and commitment to high‑quality standards.

Required skills

• Experience with electronic batch records.