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Description

Job Description: Quality Auditor II (Contract – 15 Months)

Location: Remote (U.S. Nationwide)

Travel: Up to 20% (primarily to Indiana CMO site)

Schedule: Must be able to align with an East Coast–based team

Contract Duration: 15 months

Position Overview

• The Quality Auditor II will provide quality oversight for an aseptic medical device product manufactured at a Contract Manufacturing Organization (CMO) site located in Indiana.
• This role focuses heavily on CMO management, quality assurance activities, batch documentation review, and compliance oversight. The position is fully remote with periodic travel to the CMO.
• You will partner closely with cross-functional virtual teams including Quality, Operations, Technical, Engineering, GCMC, and Regulatory groups.

Key Responsibilities

CMO Quality Oversight (Primary Focus – ~80%)

• Manage day-to-day quality oversight of the CMO manufacturing operations.
• Build and maintain a strong working relationship with the CMO’s quality and operations teams.
• Travel to the Indiana manufacturing site as needed, especially during onboarding and initial phases.
• Conduct oversight related to aseptic processes and ensure compliance with internal and external standards.
• Participate in virtual site operating team meetings and cross-functional project discussions.

Quality Assurance Activities

• Review batch records, validation protocols, engineering run protocols, and other GMP documentation.
• Support investigations, deviation management, and root cause analyses.
• Prepare and manage change controls as needed.
• Ensure operations meet cGMP requirements and quality expectations.

Regulatory Support (~20%)

• Collaborate with internal GCMC and Regulatory Affairs partners.
• Understand regulatory considerations impacting product manufacturing at the CMO.
• Ensure documentation and quality processes align with regulatory expectations.

Required Skills & Experience (Must-Haves)

• Quality Assurance / Quality Management experience (ideally 7+ years).
• Regulatory experience sufficient to interface effectively with regulatory and GCMC teams.
• Aseptic manufacturing experience (highest priority due to product risk profile).

Preferred Skills

• Experience managing or overseeing CMO relationships.
• Strong understanding of aseptic operations in a GMP environment.
• Experience with aseptic medical device manufacturing is ideal.
• Ability to navigate complex cross-functional environments and virtual team structures.

Work Environment & Team Structure

• Fully remote team based primarily in the U.S.
• Hiring manager and most team members operate on Eastern Time.
• Cross-functional partners are geographically dispersed.
• Collaboration occurs primarily through virtual meetings, with in-person interactions during CMO site visits.

Travel Requirements

• Up to 20% travel, primarily to the Indiana CMO site.
• No international travel expected.