Sr. Specialist, Quality Assurance

The businesses of Merck KGaA, Darmstadt, Germany•Indianapolis, IN

5d•$85,000 - $156,100•Hybrid

About The Position

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.

Requirements

5-7+ years of progressive experience in a QA or related role to job duties within a cGMP-regulated pharmaceutical, biotechnology, or drug product manufacturing environment
Prior experience as an eQMS or LMS administrator (e.g., Veeva Vault, TrackWise, SAP, or equivalent platform)

Nice To Haves

Bachelors degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field)
Demonstrated experience supporting or participating in FDA or other regulatory agency inspections

Responsibilities

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.
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.
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.
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 Document Control, Issuance, Batch Record Review, and Training as assigned.
Contribute to Deviation and CAPA investigations as a supporting team member, particularly for issues related to documentation practices, training compliance, and batch record errors.
Assist and complete all other tasks and projects as assigned.