Senior QA Compliance Specialist, Pharma Quality & Audits

Regulatory Jobs; Rochester (MI); Presencial; USD 83.000 - 138.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan with Pfizer Matching Con‑

Paid vacation, holiday and personal

Health benefits to include medical, Rx

Relocation assistance may be available

Descripción de la vacante

Pfizer is seeking a Quality Systems professional in the United States to evaluate CAPA responses, maintain QA policies, and support regulatory inspections, internal audits, and supplier assessments, ensuring timely action and compliance.

You will investigate customer complaints, collaborate with manufacturing sites and partners, analyze data, and drive continuous improvement while upholding cGMP, data integrity, and regulatory expectations.

Formación

• Quality investigations related to pharmaceutical or medical device manufacturing processes.
• Understanding of Quality System functions, manufacturing and packaging processes, validations, drawings, and basic statistics.
• Ability to apply statistics to Quality Engineering tasks.
• Excellent technical writing, communication, and presentation skills.
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software.
• Experience in preparing and participating in audits and inspections.

Responsabilidades

• Evaluate CAPA responses for adequacy, effectiveness, and timeliness.
• Ensure QA policies and records remain compliant with regulatory requirements.
• Prepare for regulatory inspections and audits; develop and close action plans.
• Manage and document customer quality complaints; root cause analysis.
• Collaborate with internal stakeholders to complete investigations and records.
• Support Supplier Quality Management program.
• Assist with technical investigations and testing protocols.
• Collect and analyze quality data to identify improvement opportunities.
• Review quality system documentation and metrics; identify issues.
• Promote cGMP compliance and data integrity.
• Support investigations, deviation/change management, and continuous improvement.
• Prepare reports and quality metrics for management.

Conocimientos

Quality investigations

Audits

Statistical analysis

Technical writing

Communication skills

Educación

High school diploma with 8+ years

Associate’s degree with 6+ years

BA/BS with 2+ years

MBA/MS with any years

Herramientas

Microsoft Office

Microsoft Project

Statistical Software

Descripción del empleo

Pfizer is seeking a Quality Systems professional in the United States to evaluate CAPA responses, maintain QA policies, and support regulatory inspections, internal audits, and supplier assessments, ensuring timely action and compliance.

You will investigate customer complaints, collaborate with manufacturing sites and partners, analyze data, and drive continuous improvement while upholding cGMP, data integrity, and regulatory expectations.