Summary: The Specialist Quality Assurance will play a key role in supporting Quality Assurance program by performing quality oversight, risk assessments, and compliance activities for manufacturing processes.
This position ensures adherence to regulatory standards and internal procedures, collaborating across departments to drive process improvements, manage compliance, and serve as a representative for QA on cross-functional teams.
Key Responsibilities: Review and approve manufacturing processes (MPs) and validation protocols/reports.
Represent Quality Assurance on incident triage and New Product Introduction (NPI) teams.
Lead site audits, investigations, and environmental characterization assessments.
Oversee the release of sanitary utility systems and approve planned incidents and risk assessments.
Serve as a QA designee on the local Change Control Review Board (CCRB).
Approve non-conformance (NC) investigations, Corrective and Preventive Actions (CAPA) records, and change controls.
Authorize lot disposition for shipment and oversee lot approvals.
Support automation, facilities, and environmental programs as required.
Review and approve work orders, EMS/BMS alarms, and quality program procedures.
Experience: Expertise in quality systems such as Deviations, CAPA, and Change Control.
Hands-on experience with electronic documentation systems, including CDOCS, Maximo, Trackwise, LIMS, MES, and SAP.
Demonstrated experience in GxP application validation, validation master planning, IQ, OQ, PQ protocols, risk assessment, and summary reports.
Proven track record as a Quality Contact for projects involving new drug products and extensive experience with equipment and utility qualifications.
Key Skills: Leadership and project management in quality-related initiatives.
Strong organizational abilities, attention to detail, and follow-through.
Ability to interact with all levels within the organization and work independently.
Advanced analytical skills for evaluating compliance issues and identifying process improvements.
Requirements Education: Doctorate in Science/Engineering, OR Master's degree in Science/Engineering with 3+ years of related experience, OR Bachelor's degree in Science/Engineering with 5+ years of related experience, OR Associate's degree with 10+ years of related experience, OR High school diploma / GED with 12+ years of related experience.
Preferred Qualifications: Strong communication and presentation skills in both English and Spanish.
Advanced skills in project management, data trending, and independent problem-solving.
Enhanced ability to lead cross-functional teams, influence others, and negotiate effectively.
Experience collaborating with regulatory agencies and addressing compliance issues.
Proficient with word processing, presentation, database, and spreadsheet software.
Shift Details: 5 days, 8 hours per day.