Job Summary

What you'll do

• Monitor batch processing activities to ensure compliance with approved procedures, batch records, and current Good Manufacturing Practices (cGMP).
• Conduct routine inspections of manufacturing operations, equipment, systems, utilities, and facilities using established checklists.
• Perform in-process quality oversight on the production floor and support real-time resolution of compliance-related issues.
• Review production logbooks and batch records, including verification of critical manufacturing parameters.
• Support plasma and component inspection activities to ensure product quality and compliance.
• Track, document, trend, and analyze operational observations to support site quality metrics and key performance indicators.
• Initiate and document minor non-conformance reports.
• Support Return to Service activities and related quality documentation.
• Review critical system and utility alarms for compliance and operational impact.
• Review work orders, preventive maintenance documentation, and calibration records to verify compliance requirements.
• Assist with the revision and maintenance of Standard Operating Procedures (SOPs) and GMP documentation.
• Participate in cross-functional and departmental initiatives focused on continuous improvement and quality performance.
• Support quality investigations, deviation management activities, change controls, corrective actions, and other quality systems as assigned.
• Maintain accurate and timely documentation in accordance with GMP and GDP requirements.
• Promote and follow all site safety policies, procedures, and regulatory requirements.
• Collaborate effectively with Quality, Manufacturing, Engineering, and other operational teams to support manufacturing readiness and compliance.
• Perform additional duties and assignments as required to support business and operational needs.

Qualifications and need-to-know

• College degree preferred or equivalent combination of education and relevant experience required.
• Experience within a pharmaceutical manufacturing, Quality, or Operations environment preferred.
• Experience supporting biologics manufacturing, Quality Assurance, or manufacturing operations is a plus.
• Knowledge of GMP and GDP regulations and working in a regulated pharmaceutical environment.
• Experience with plasma fractionation, aseptic filling, or labeling operations is preferred.
• Experience with pharmaceutical investigations, deviations, or quality systems is a plus.
• Ability to review and interpret manufacturing documentation, batch records, logbooks, and compliance records.
• Strong written and verbal communication skills.
• Demonstrated problem-solving skills and attention to detail.
• Proficiency with Microsoft Office applications and email systems.
• Ability to work effectively in a team-oriented manufacturing environment.
• Commitment to following safety procedures, company policies, and applicable regulatory requirements.
• Ability to complete required training and perform responsibilities in accordance with approved SOPs and quality standards.