Specialist, Quality Assurance

Merck•Indianapolis, IN

16d•Onsite

About The Position

In this role you will perform Quality Document Control and Product Release activities within a complex parenteral manufacturing facility, including Batch Record Review and Product Release, Batch Record Issuance, Document Control/Archival, and related investigations/CAPAs and Training. The position collaborates with other QA personnel, Quality Control, Operations, Clients, and Suppliers to establish and maintain requirements for product release and document management. Responsible for ensuring that all products manufactured and/or supported meet established specifications and regulatory requirements.

Requirements

High School Diploma or GED.
2+ years of quality assurance experience within GMP regulated environment.

Nice To Haves

Bachelor’s Degree.
Knowledge of product-specific manufacturing processes, equipment, and in-process controls associated with commercial/clinical products manufactured to support effective and knowledgeable batch record review preferred
Ability to operate with a high level of autonomy and collaborate effectively with others.
Essential knowledge of cGMPs.
Strong oral and written communication skills, including internal and external interface.
Ability to train and qualify others in pharmaceutical manufacturing quality activities.
Strategic perspective with self-motivation, resilience, team orientation, and results-driven approach.

Responsibilities

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.
Evaluate completed batch records for accuracy, completeness, legibility, proper documentation practices (GDP), and compliance with approved manufacturing instructions, in-process specifications, and acceptance criteria.
Identify, document, and communicate errors, omissions, and discrepancies found during batch record review, working directly with Manufacturing personnel and frontline supervisors to initiate timely and appropriate corrections in compliance with GDP requirements.
Initiate or support the initiation of deviations and investigations in the eQMS for batch record discrepancies that cannot be corrected via standard GDP correction practices, ensuring proper escalation and documentation.
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.