Manufacturing Quality Assurance Specialist

Manufacturing Quality Assurance Specialist

Join to apply for the Manufacturing Quality Assurance Specialist role at Fagron Sterile Services US (FSS).

The MQA Specialist reports to the Manufacturing Quality Manager and works closely with Operations personnel and Environmental Monitoring Technicians to complete on‑floor audits and training of behavior and technique.

• Identify and report QA events related to maintenance of aseptic conditions within clean rooms with a focus on sterility assurance during manufacturing operations.
• Perform timely and accurate process review of batch records and QA checks within the manufacturing process.
• Review production specific deviations/Investigations, CAPAs, and Change Controls.
• Generate procedures related to Manufacturing QA functions and activities.
• Observe and identify conformance to defined procedures and batch specific steps within the aseptic areas.
• Periodically review records to verify that quality standards for each drug product are met.
• Maintain compliance with FDA 503B and cGMP guidelines, state and federal laws.
• Prepare weekly/monthly reports, metrics and trends data to identify and prioritize continuous improvement opportunities.
• Maintain all testing equipment in compliance, calibration and certification.
• Assist in developing policies and procedures related to QA.
• Promptly communicate with Operations regarding complaints, product issues and variances.
• Assist in maintaining compliant controlled substance documentation associated with sample handling and reconciliation.
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles; support all regulatory and customer quality audits.
• Gather, organize and analyze data to develop solutions and alternative methods of proceeding compliantly.
• Assist CAPA teams and other project teams in developing action plans, implementation schedules, and verification of completed actions.
• Conduct periodic internal reviews or audits to ensure compliance procedures are followed.
• Conduct and report findings of internal investigations of compliance issues.

• High School Diploma with a BS/BA degree preferred.
• Minimum 2 years of pharmaceutical experience within a quality/compliance function.
• Ability to multi‑task, effectively communicate, and make decisions independently.
• Oversight of operations with a focus on sterility assurance.
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Environmental monitoring or audit experience is an asset.
• Experience with inspections and inspection readiness activities is an asset.