Senior QA Consultant (Pharma & Devices)

Oxford Global Resources; Lebanon (IN); On-site; USD 73,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays and sick leave

Job summary

Oxford is seeking a quality-focused professional to perform tactical work and review a variety of documents, protocols, and reports for API and drug product used in clinical studies.

You will review manufacturing records, change controls, investigations, analytical data, test methods, and validation protocols, collaborating with cross-functional teams to ensure compliant, timely documentation.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related discipline.
• 5+ years of work experience in Quality within Medical Device and/or Pharmaceutical companies.
• Experience with CAPA, root cause investigation, validation (process, test method, software, design).
• Knowledge of Environmental Monitoring, manufacturing operations, planning, and supply chain.

Responsibilities

• Document, review and batch disposition of API and drug product for Phase 1-3 studies.
• Review and approve manufacturing records, change controls, investigations and analytical data.
• Review and approve test methods and method validations.
• Review manufacturing validation protocols and reports.

Skills

Small molecule manufacturing

Contract manufacturing

Analytical skills

Communication skills

Project management

Quality systems knowledge

Education

Bachelor's degree in Engineering/ Chemistry/ Biology

Job description

Oxford is seeking a quality-focused professional to perform tactical work and review a variety of documents, protocols, and reports for API and drug product used in clinical studies.

You will review manufacturing records, change controls, investigations, analytical data, test methods, and validation protocols, collaborating with cross-functional teams to ensure compliant, timely documentation.