Sr. Specialist, Quality Assurance

 

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

The Senior Specialist, Quality Assurance is a critical, hybrid role within the commercial drug product manufacturing quality organization. This position carries direct responsibility across four core quality systems: Document Control, Document Issuance, Batch Record Review, and Training Administration. The incumbent serves as a subject matter expert (SME) and operational backbone for maintaining the integrity of the site’s quality management system (QMS) in full compliance with current Good Manufacturing Practices (cGMP).

This role requires a highly organized, detail-oriented professional who can independently manage competing priorities, communicate effectively across functional teams, and uphold the highest standards of data integrity and regulatory compliance. The Senior Specialist operates with a high degree of autonomy while collaborating cross-functionally with all departments at the site.

Core Responsibilities:

1. Document Control

• Serve as a primary site administrator and SME for the Electronic Document Management System (EDMS)
• Maintain the site’s document control metrics, including cycle time, overdue reviews, and present findings at quality system review meetings.

 

2. Document Issuance

• Manage the issuance, reconciliation, and controlled distribution of all cGMP documents used on the manufacturing floor, including Batch Manufacturing Records (MPCRs), logbooks, and associated controlled forms.
• Maintain the issuance room and staging areas in an organized, audit-ready state, with clear segregation of issued, returned, and archived documents.

 

3. Batch Record Review

• Perform thorough, quality review of completed Batch Manufacturing Records (MPCRs) and associated executed cGMP documents for commercial drug product lots in accordance with site SOPs and applicable regulatory requirements.
• Collaborate with the Batch Record Review team and Manufacturing to drive continuous improvement in documentation quality, reducing recurring errors through targeted feedback, trend analysis, and retraining recommendations.
• Track and report batch record review cycle times to support on-time lot disposition and maintain alignment with established release timelines.
• Maintain working knowledge of the product-specific manufacturing processes, equipment, and in-process controls associated with all commercial products manufactured at the site to support effective and knowledgeable batch record review.

 

4. Training Administration

• Serve as a site Training Administrator within the Learning Management System (LMS), managing training curricula, assignments, completion tracking, and training record maintenance for all cGMP personnel.
• Maintain accurate and complete training records for all site personnel in compliance with cGMP requirements, ensuring records are readily retrievable for regulatory inspections, audits, and internal quality reviews.
• Coordinate and support the onboarding training process for new cGMP employees, ensuring initial training curricula are assigned in the LMS and completed prior to independent work on the manufacturing floor.
• Maintain the site’s training metrics dashboard, tracking completion rates by department, role, and document type, and present findings during quality system review meetings.

 

Cross-Functional and General Quality Responsibilities

• Actively participate in internal audits, mock inspections, and regulatory agency inspections, providing direct support for Docume