This job was last updated on January 30, 2026 10:42 AM.

Job Title: Senior QA Investigations Specialist (503B / Pharmaceutical)

About the Company

Our client is a regulated pharmaceutical outsourcing facility (503B) specializing in compounded hormone and therapeutic wellness medications. The organization operates under strict FDA, GMP, and internal quality standards and is seeking a senior-level quality professional to lead investigations and corrective action activities.

Position Overview

The Senior QA Investigations Specialist is responsible for leading, authoring, and closing quality investigations related to deviations, nonconformances, and process failures within a pharmaceutical manufacturing environment. This role requires deep expertise in deviation writing, CAPA development, and root cause analysis, along with the ability to guide cross-functional teams through complex investigations.

This is a hands-on, subject-matter-expert role, not an entry-level or documentation-only position.

Schedule & Pay

• Monday–Friday, 8:00 AM–5:00 PM
• On-site, full-time
• Pay: Hourly $27-36/hr

Key Responsibilities

• Lead and author deviation reports, CAPAs, and nonconformance reports (NCRs) in a regulated pharmaceutical environment
• Perform and document root cause investigations using formal methodologies (e.g., 5 Whys, Fishbone, risk-based analysis)
• Partner with Manufacturing, QC, Validation, and Engineering teams to investigate events and define effective corrective and preventive actions
• Ensure investigations are completed thoroughly, on time, and in compliance with FDA, cGMP, and 503B requirements
• Review trends, recurring issues, and systemic risks; recommend quality system improvements
• Support internal and external audits, including FDA inspections, by providing investigation documentation and responses
• Act as a technical mentor and resource to junior QA staff and cross-functional teams
• Ensure all investigation documentation meets GDP standards and internal quality expectations

Required Qualifications

• 4–5+ years of direct QA investigations experience in pharmaceutical manufacturing or 503B compounding
• Demonstrated experience writing and owning deviations, CAPAs, and NCRs
• Strong working knowledge of cGMPs, FDA regulations, and quality systems
• Proven ability to conduct and document root cause analysis beyond surface-level findings
• Experience working cross-functionally in a production-facing environment
• High attention to detail with strong technical writing skills
• Ability to lead investigations with confidence and authority

Preferred Experience

• 503B outsourcing facility experience
• Sterile or non-sterile pharmaceutical manufacturing
• FDA inspection readiness and audit response experience
• Quality systems software (eQMS) experience

Who This Role Is Not For

• Entry-level QA professionals
• Documentation reviewers without investigation ownership
• Candidates without hands-on deviation/CAPA writing experience