Quality Auditor - III

Title: Quality Auditor - III

Location: 1 BURTT ROAD, Andover, MA, USA, 01810

Duration: 12+ months (possible for extensions)

Remote Position

Job Description:

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.

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
Cross functional partners are geographically dispersed.
Collaboration occurs primarily through virtual meetings, with in person interactions during CMO site visits.External Supply Operations Quality (ESOQ Manager)

Qualifications:
Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role
At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms
Command of English language required and multi-lingual is a benefit
Strong verbal and written communication including presentation skills
Shows strong negotiation skills and is diplomatic in communication with internal and external customers
Demonstrated ability to manage multiple projects and priorities
Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader
Demonstrated excellent organization skills
Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
Developing personal leadership to manage cross functional projects
Developing ability to resolve conflicts
Takes initiatives and is proactive, persistent
Has a broad GMP and technical know-how to handle emerging issues
Able to report remotely and deliver work independently
Up to 20% travel may be required

Regards,

Pavan

Email:

Infobahn Soft World Inc, 2010 N 1st Street,

St#470, San Jose, CA 95131, USA.