Manufacturing Quality Assurance

Job Overview
We are seeking an experienced Manufacturing Quality Assurance (QA) Specialist to provide direct, on-the-floor quality oversight and support for pharmaceutical manufacturing operations within a GMP-regulated environment.

The ideal candidate will have extensive hands-on experience in pharmaceutical manufacturing quality assurance, ensuring that production activities, processes, equipment, documentation, and personnel practices comply with established procedures, regulatory requirements, and quality standards.

This position requires a strong presence on the manufacturing floor, providing real-time quality guidance, identifying potential compliance risks, supporting investigations, and collaborating with Manufacturing, Engineering, Validation, and Quality teams to maintain product quality and operational compliance.

Key Responsibilities
On-the-Floor Quality Assurance & Manufacturing Oversight
• Provide direct QA support and oversight for daily pharmaceutical manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality standards.
• Perform routine manufacturing floor walkthroughs and inspections to verify compliance with operational procedures, documentation practices, and quality requirements.
• Monitor critical manufacturing activities, including equipment preparation, line clearance, material handling, production execution, and in-process controls, as applicable.
• Verify that manufacturing activities are performed according to approved batch records, Standard Operating Procedures (SOPs), and established process parameters.
• Identify, document, and escalate potential quality issues, procedural discrepancies, and GMP compliance risks.
• Provide real-time quality guidance and support to manufacturing personnel during routine operations and unexpected events.

Batch Record Review & Documentation Compliance
• Review manufacturing batch records, electronic records, logbooks, and associated production documentation for accuracy, completeness, and GMP compliance.
• Verify adherence to Good Documentation Practices (GDP) and applicable data integrity requirements.
• Identify documentation discrepancies, missing information, and procedural inconsistencies, coordinating timely resolution with Manufacturing personnel.
• Support batch record reconciliation, manufacturing documentation review, and batch disposition activities within assigned responsibilities.
• Ensure that manufacturing records accurately reflect executed operations and maintain appropriate traceability.

Deviations, Investigations & CAPA
• Support the identification, documentation, and investigation of manufacturing deviations, nonconformances, and quality events.
• Collaborate with Manufacturing and technical teams to evaluate potential product quality impacts and determine appropriate containment actions.
• Participate in root cause investigations using established problem-solving methodologies.
• Review and support the implementation of Corrective and Preventive Actions (CAPA) to address identified quality issues.
• Monitor the effectiveness of corrective actions and support timely closure of quality events.
• Provide QA input regarding manufacturing discrepancies, procedural deviations, and potential compliance risks.

Change Control & Quality Systems
• Support the evaluation and implementation of change controls affecting manufacturing processes, equipment, materials, facilities, and operational procedures.
• Review proposed changes to assess potential impacts on product quality, regulatory compliance, and validated processes.
• Collaborate with Engineering, Validation, and Manufacturing teams to ensure appropriate quality oversight during process modifications and equipment-related activities.
• Support the review and revision of SOPs, manufacturing instructions, and other controlled documents.
• Participate in quality system improvement initiatives to strengthen manufacturing compliance and operational efficiency.

GMP Compliance, Audits & Continuous Improvement
• Ensure manufacturing activities comply with applicable FDA regulations, including 21 CFR Parts 210 and 211, and established cGMP requirements.
• Support internal audits, regulatory inspections, and quality assessments related to manufacturing operations.
• Identify opportunities to improve GMP compliance, documentation practices, and manufacturing quality performance.
• Provide quality guidance to manufacturing personnel regarding procedural compliance, documentation expectations, and quality standards.
• Participate in cross-functional meetings to address manufacturing quality concerns, operational challenges, and continuous improvement initiatives.
• Promote a strong quality culture through proactive communication, risk identification,