Quality Assurance Specialist(Deviations)

• Conduct minor, major, and critical deviation investigations in their respective areas as necessary and will document such investigations appropriately. • Lead root cause analysis investigations with team members to identify problems and deviations during the project, determine product impact, and assign appropriate CAPAs with responsibilities and due dates within the team. • Perform trend analysis to identify and report adverse trends and deviations that may require further action.• Bachelor''s degree from an accredited college/university. • At least 3-5 years of experience in pharmaceutical industry, with biologics and/or biotech products preferred. • Appropriate written and verbal communication skills in English and in any other relevant language(s). • Knowledge and experience with aseptic processing in pharma/biotech manufacturing. • Expert level understanding of deviation resolution for manufacturing processes and CAPA management. • Previous experience with remediation plans for the FDA. • Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)

Created: 2025-11-15