QA Auditor - cGMP Compliance & CAPA Lead

BioSpace; Swiftwater (Monroe County); Sur place; USD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Health and wellbeing benefits

14 weeks parental leave

Global vaccine delivery mission

Résumé du poste

Sanofi Inc. in Swiftwater, PA is seeking a Quality Assurance Specialist to ensure cGMP compliance across manufacturing, testing, and distribution.

You will lead audits, investigations, training, and improvements to prevent regulatory issues and protect patient safety. The role requires a Bachelor's degree and 3+ years in GMP QA, with strong data analysis, attention to detail, and effective communication with regulatory bodies.

Qualifications

• Bachelor's degree required in a relevant field.
• 3+ years of QA experience in a GMP-regulated environment.
• Experience accessing aseptic processing areas and sterile gowning.
• Ability to analyze complex data and identify trends and solutions.
• Strong attention to detail in QA activities.

Responsabilités

• Maintain audit readiness and address observations on schedule.
• Support production compliance including aseptic areas and testing.
• Perform cGMP audits and report deficiencies with corrective actions.
• Manage CAPA system and drive process improvements.
• Support Change Control with assessments and data.
• Provide final sign-off on SOPs and master records.
• Communicate quality performance and corrective actions to stakeholders.
• Engage with internal and external auditors as needed.

Connaissances

Data analysis

Attention to detail

Communication skills

Quality assurance

Formation

Bachelor's degree

Description du poste

Sanofi Inc. in Swiftwater, PA is seeking a Quality Assurance Specialist to ensure cGMP compliance across manufacturing, testing, and distribution.

You will lead audits, investigations, training, and improvements to prevent regulatory issues and protect patient safety. The role requires a Bachelor's degree and 3+ years in GMP QA, with strong data analysis, attention to detail, and effective communication with regulatory bodies.