Senior QA Specialist - cGMP API Release & Compliance

Jobtailor; Rahway (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking an experienced Quality Assurance professional to lead GMP-compliant API manufacturing quality activities in a complex clinical supply development, based in New Jersey. You will review and approve GMP documents, perform independent batch release decisions, and lead audits, CAPAs, and deviations to ensure compliant product release.

Candidates should possess a BS in a science or engineering discipline with 5+ years in pharma, strong communication, and proficiency with Microsoft

Qualifications

• Bachelor degree in science or engineering field.
• Minimum 5 years’ experience with a B.S.
• Experience in the pharmaceutical or closely related industry.
• GMP or related drug regulation knowledge and expertise.

Responsibilities

• Review and approve GMP documents.
• Perform independent batch release or reject decisions.
• Audit, review, and approve diverse document types including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
• Support compliance activities such as site readiness, audits, inspections, and CAPAs.
• Establish, educate, and enforce SOPs required under GMP.
• Build collaborative relationships with stakeholders across manufacturing operations, QA, regulatory, and other functions.
• Provide quality guidance and deliverables to cross-functional teams.

Skills

Quality Assurance

CGMP Compliance

Project Management

Analytical Method Validation

Leadership

Education

Bachelor's degree in Science/Engineering

Tools

Microsoft Suite

Electronic Systems

Job description

Jobtailor is seeking an experienced Quality Assurance professional to lead GMP-compliant API manufacturing quality activities in a complex clinical supply development, based in New Jersey. You will review and approve GMP documents, perform independent batch release decisions, and lead audits, CAPAs, and deviations to ensure compliant product release.

Candidates should possess a BS in a science or engineering discipline with 5+ years in pharma, strong communication, and proficiency with Microsoft