Operational Quality Specialist

Position Summary:

You will provide operational quality oversight at a United States manufacturing site. Work with production, laboratories, engineering, and quality teams to keep processes compliant, safe, and reliable; maintain adherence to cGxP standards; provide independent oversight of GxP processes; maintain batch record review/approval, quality decision-making, and quality escalations; and liaise with QA Systems, QA Compliance, and QA Product Release (QAPR).

• Ensure GMP processes and personnel meet current GMP and applicable regulatory requirements; maintain inspection readiness.
• Provide shopfloor oversight; first contact for initial quality issue management and quality escalations.
• Observe GMP activities in real time to proactively detect potential quality issues and enable timely interventions.
• Perform spot-checks across production and laboratory areas (production, testing, cleaning, maintenance).
• Review cGMP documentation/data for ALCOA+ data integrity and GDP; review and approve batch records and related documentation.
• Review/approve deviations and associated CAPA plans; review documentation including procedural revisions, logbooks, PQRs, complaint investigations, change controls, and validation documents.
• Ensure GMPs, validation, quality, safety, and environmental regulations are met.
• Coach employees on compliance, procedure adherence, and patient safety impact.
• Support disposition/lot release and self‑inspections/internal audits/inspection readiness.
• Review/approve GMP documentation updates (change controls, validation summaries); investigate quality issues and support root cause analysis and corrective/preventive actions.

• Bachelor's degree in biology/chemical engineering/life sciences (or other discipline with technical depth).
• 2+ years in regulated industry; strong QA background; biologics manufacturing strongly preferred; experience in pharma facilities/equipment/quality systems.
• 1+ years with GMPs and NIH/FDA/other regulatory compliance.
• Validation principles, aseptic processing, quality systems, and FDA regulations; DMAIC training; batch record/GMP documentation review.

• Biologics/pharma experience with deviations, CAPA, change control, and validation; root cause analysis methods (DMAIC or similar).
• Inspection readiness and regulatory expectations; ability to influence teams and coach on quality behaviors; fast‑paced prioritization.
• Strong communication and interpersonal skills; foster "Quality Starts With Me" culture; continuous improvement.