Job Summary

What you'll do

• Provide quality oversight and GMP support for daily manufacturing operations.
• Monitor batch processing activities to ensure compliance with approved procedures, batch records, and cGMP requirements.
• Conduct routine inspections of production activities, manufacturing areas, utilities, systems, and facilities.
• Review production logbooks, batch records, and supporting documentation for completeness, accuracy, and compliance.
• Verify critical manufacturing parameters and support in-process quality reviews.
• Support plasma and component inspection activities.
• Identify, document, and communicate compliance observations and quality concerns in a timely manner.
• Track and trend quality observations to support site performance metrics and continuous improvement initiatives.
• Initiate and document minor non-conformance events.
• Support Return to Service activities and associated quality documentation.
• Review utility alarms, maintenance records, work orders, and calibration documentation to ensure compliance requirements are met.
• Assist with the revision and maintenance of SOPs and other GMP-controlled documents.
• Support investigations, deviations, corrective actions, and change control activities as assigned.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support operational excellence.
• Maintain accurate records and documentation in accordance with GMP and GDP requirements.
• Follow all safety policies, procedures, and regulatory standards.
• Perform additional duties and project work as required to support site objectives.

Qualifications and need-to-know

• College degree preferred or equivalent combination of education and relevant experience required.
• Experience in pharmaceutical manufacturing, Quality Assurance, Quality Operations, or production environments preferred.
• Knowledge of GMP and GDP regulations and experience working in a regulated environment.
• Experience with biologics manufacturing, plasma fractionation, aseptic filling, or labeling operations is a plus.
• Experience supporting investigations, deviations, non-conformances, or quality systems is preferred.
• Strong attention to detail and ability to review technical documentation accurately.
• Effective verbal and written communication skills.
• Demonstrated problem-solving and organizational abilities.
• Proficiency with Microsoft Office applications and email systems.
• Ability to work effectively in a team-oriented manufacturing environment.
• Commitment to safety, quality, regulatory compliance, and continuous improvement.