Associate III – Integrated Downstream Quality Operations

Competences:

• Provide QA shopfloor oversight for downstream manufacturing operations
• Review electronic batch records (eBR), electronic logbooks, LIMS records and samples
• Review and approve GMP Manufacturing and Engineering documentation
• Manage minor and major deviations and support investigations
• Support CAPAs, change controls and equipment-related quality activities
• Provide Quality oversight for equipment qualification , work orders, P&IDs, qualification protocols and calibration deviations
• Support column packing/unpacking and chromatography review and release
• Perform Quality oversight of PLM, CMMS and Kneat activities
• Participate in batch record review and close-out in preparation for batch release
• Support equipment controls and release during GMP CAPEX/OPEX projects, shutdowns and new product introductions
• Participate in the Quality On-Call rotation
• Collaborate cross-functionally to ensure compliance with applicable GMP and regulatory requirements
• Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations or a related field with at least 6 years of relevant pharmaceutical/biotech manufacturing experience OR Master’s degree in a relevant field with at least 4 years of relevant pharmaceutical/biotech manufacturing experience
• Experience within a GMP pharmaceutical or biotechnology manufacturing environment
• Experience in Quality Assurance ; exposure to downstream processing and equipment qualification is strongly preferred
• Experience with deviations, investigations and GMP documentation
• Understanding of downstream manufacturing operations and equipment
• Ability to work autonomously and effectively with cross-functional teams
• Strong organizational, writing, presentation and problem-solving skills