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 timelines

• Trend AQL failures and support root cause analysis investigations for quality incidents, implementing preventive measures as needed

• Ensure all batch release activities comply with GMP requirements

• Manage the sampling, storing, monitoring, and maintenance of finished product retention samples according to established procedures and timelines

• Perform and manage annual inspections of retention samples

• Support the creation of new material and product specifications

• Perform document creation and revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines

• Support the department Quality Management System, including Change Control, Deviations, and CAPA processes

• Support the department documentation archival system

• Collaborate closely with production on the shopfloor to ensure quality standards are maintained throughout the product lifecycle

• Manage, escalate, and resolve quality-related issues in a timely and effective manner

• Support monitoring and analysis of quality performance metrics, implementing corrective actions as needed

• Conduct internal audits of manufacturing processes to verify ongoing compliance with in-house specifications and government regulations

• Establish auditing requirements, quality standards, and test methods in accordance with applicable regulations

• Review, document, and complete inspections of returned goods

• Support quality walkthroughs and participate in internal and external audits and regulatory inspections as a subject matter expert

• Support risk management strategies to identify and mitigate potential quality issues

• Foster a culture of quality and continuous improvement across the organization

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures

• Contribute 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 regulations

• Proficiency in interpreting complex regulatory, technical, and explicit documentation to ensure adherence to quality and compliance requirements

• Solid understanding of government regulations related to manufacturing compliance

• Ability to establish and implement quality standards, auditing frameworks, and test methodologies

• Excellent analytical and problem-solving skills with sound judgment in ambiguous situations

• Strong written and verbal communication skills for internal and external stakeholder engagement, including the ability to advise on risk management strategies and present findings effectively

• High attention to detail with a commitment to accuracy and thoroughness

• Ability to work independently, manage multiple priorities, and operate effectively on a 2nd shift schedule

• Demonstrated ability to contribute to and support cross-functional organizational goals

• Proven 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 role

• Proven experience conducting internal audits of manufacturing processes

• Experience establishing auditing frameworks, quality standards, and test methods

• Track record of working with GMP requirements, government regulations, and in-house compliance specifications

• Experience managing batch release activities, retention samples, and finished product inspections

• Experience supporting Quality Management Systems, including Change Control, Deviations, and CAPA

• Experience participating in internal and external audits and regulatory inspections, including serving as a subject matter expert

• Experience representing an organization in project-based or cross-functional capacities