Quality Assurance Specialist

Sanofi • Pocono Township, PA

23h • $58,500 - $84,500 • Onsite

About The Position

The Quality Assurance Specialist ensures compliance with cGMP, regulatory, and internal requirements for manufacturing, testing, and product distribution. The role conducts audits, investigations, and training, and recommends improvements to processes and procedures. It evaluates products, systems, and issues that are or may be affected by regulatory or cGMP requirements.

This role provides daily floor coverage across production, development, and testing activities, including aseptic processing and AQL sampling. It supports inspection readiness, manages corrective and preventive actions and change controls, reviews controlled documents, and communicates quality requirements to site stakeholders and auditors. The position is based in Swiftwater, Pennsylvania, and is described as a first-shift role, with Sun–Thurs or Tues–Sat schedules and possible off-shift work depending on business needs.

Requirements

• Bachelor's degree.
• Three or more years of quality experience is preferred, preferably in a GMP-regulated environment.
• Ability to access aseptic processing areas; sterile gowning is required for relevant work.
• Exceptional eyesight and sampling technique for AQL sampling activities.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High accuracy and attention to detail in quality assurance activities.
• Strong verbal and written communication skills for interacting with team members and regulatory bodies.
• Ability to identify problems and implement effective corrective actions.
• Ability to manage multiple projects simultaneously and complete them on time while meeting quality standards.

Responsibilities

• Maintain inspection readiness and ensure audit observations are addressed and completed on time.
• Provide daily floor coverage to support production, development, and testing compliance; audit functional areas against cGMP, regulatory, and internal requirements.
• Perform Parallel and CCA Sampling as required by the business.
• Conduct cGMP audits, identify and communicate compliance deficiencies, recommend corrective actions, and monitor compliance with functional area management.
• Complete risk assessments and minor and major incident investigations for unexplained manufacturing events and out-of-specification laboratory results; guide investigation teams.
• Manage the CAPA system, ensure actions are completed on time, and recommend CAPAs for process improvement.
• Support the Change Control System by providing assessments, closure, and monitoring, and recommending documentation and supporting data to evaluate cGMP impacts and mitigate risk.
• Provide final signatory review of SOPs, SWIs, and Master Manufacturing Records for compliance.
• Communicate cGMP requirements and coordinate with site counterparts on manufacturing, testing, disposition, and cold-chain documentation.
• Interact with internal and external audit bodies and present or explain processes and documentation to auditors.
• Request corrections when GMP rules are not followed; prioritize quality and compliance; implement remediation from audit findings; request quality improvement initiatives; identify discrepancies and corrective or preventive actions; and escalate shop-floor GMP failures.
• Inform relevant stakeholders of quality performance, findings, and corrective and preventive measures; advise on presentation of topics, risk management, and initiatives that promote a quality-focused culture.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs may be available to eligible employees.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level