Compliance Specialist III – 2nd Shift (contract)

Job Title: Compliance Specialist III Location: Swiftwater, PA (on-site) Type: Contract (W2) Term: 6-months Schedule: 2nd Shift - Tuesday - Saturday from 2:00 PM - 10:30 PM ET Pay Rate Max: $55 per hour Sanofi's contingent workforce program, FLEXT Direct, is seeking a 2nd shift Compliance Specialist III for a 6-month contract. In this role, you will serve as a key contributor to maintaining the integrity of our manufacturing operations by ensuring all procedures align with in-house specifications and applicable government regulations. Operating with a high degree of independence, you will apply sound judgment to drive compliance initiatives, support organizational goals, and represent the company on specific projects. This is a critical role that directly impacts product quality, regulatory standing, and operational efficiency. Responsibilities Ensure all activities within scope are conducted in compliance with applicable regulatory requirements, including Good Manufacturing Practices (GMP)Perform finished product and AQL inspections according to established standards, specifications, and timelinesTrend AQL failures and support root cause analysis investigations for quality incidents, implementing preventive measures as neededEnsure all batch release activities comply with GMP requirementsManage the sampling, storing, monitoring, and maintenance of finished product retention samples according to established procedures and timelinesPerform and manage annual inspections of retention samplesSupport the creation of new material and product specificationsPerform document creation and revision, including periodic reviews, for department documentation according to established procedures and scheduled timelinesSupport the department Quality Management System, including Change Control, Deviations, and CAPA processesSupport the department documentation archival systemCollaborate closely with production on the shopfloor to ensure quality standards are maintained throughout the product lifecycleManage, escalate, and resolve quality-related issues in a timely and effective mannerSupport monitoring and analysis of quality performance metrics, implementing corrective actions as neededConduct internal audits of manufacturing processes to verify ongoing compliance with in-house specifications and government regulationsEstablish auditing requirements, quality standards, and test methods in accordance with applicable regulationsReview, document, and complete inspections of returned goodsSupport quality walkthroughs and participate in internal and external audits and regulatory inspections as a subject matter expertSupport risk management strategies to identify and mitigate potential quality issuesFoster a culture of quality and continuous improvement across the organizationInform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measuresContribute to the completion of organizational projects and goals, representing the organization on specific projects Skills Strong knowledge of manufacturing quality assurance principles, practices, and GMP regulationsProficiency in interpreting complex regulatory, technical, and explicit documentation to ensure adherence to quality and compliance requirementsSolid understanding of government regulations related to manufacturing complianceAbility to establish and implement quality standards, auditing frameworks, and test methodologiesExcellent analytical and problem-solving skills with sound judgment in ambiguous situationsStrong written and verbal communication skills for internal and external stakeholder engagement, including the ability to advise on risk management strategies and present findings effectivelyHigh attention to detail with a commitment to accuracy and thoroughnessAbility to work independently, manage multiple priorities, and operate effectively on a 2nd shift scheduleDemonstrated ability to contribute to and support cross-functional organizational goalsProven ability to identify discrepancies, recommend corrective and preventive actions, and escalate GMP non-compliance issues appropriately Experience 6 to 9 years of experience in quality assurance, quality control, or a related manufacturing compliance roleProven experience conducting internal audits of manufacturing processesExperience establishing auditing frameworks, quality standards, and test methodsTrack record of working with GMP requirements, government regulations, and in-house compliance specificationsExperience managing batch release activities, retention samples, and finished product inspectionsExperience supporting Quality Management Systems, including Change Control, Deviations, and CAPAExperience participating in internal and external audits and regulatory inspections, including serving as a subject matter expertExperience representing an organization in project-based or cross-functional capacities