Pharmaceutical Manufacturing Investigator

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Glenmark Pharmaceuticals Inc., USA, is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules—both New Chemical Entities (NCEs) and New Biological Entities (NBEs). Eight molecules are in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA, is a fast‑growing and robust US generics business with plans to move into the innovative market. The USA subsidiary also markets APIs to regulated and semi‑regulated countries.
Under the crucial direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by owning and investigating all Manufacturing‑related deviations. The Deviation Investigator will collaborate with cross‑functional stakeholders to perform simple and complex root cause analyses, identifying corrective actions to close assigned investigations on time.

The role will support all aspects of the Dispensing, Compounding, Sterilization, Terminal Sterilization, Lyophilization, aseptic syringe filling, aseptic vial filling, visual inspection, and packaging. The philosophy in Monroe is to become a best‑in‑class aseptic manufacturing facility.

This individual will be part of a supportive work environment, closely collaborating with cross‑functional teams at the site and abroad. They will routinely report on quality system and business process performance, proactively identifying, providing guidance, and implementing process and system improvements to resolve complex issues promptly, ensuring a smooth and efficient work process.

JOB RESPONSIBILITIES:

• Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines and company and regulatory requirements.
• Coordinates with cross-functional teams for testing of reserved or retained samples for investigation purposes, where applicable.
• Coordinates the reviews of relevant records (e.g., batch records, quality control data, quality investigations, etc.)
• Conducts root cause analysis to facilitate and initiate corrective and preventative actions wherever needed.
• Tracks quality system metrics and creates detailed trend analysis reports.
• Performs analysis of data, trending, and provides metrics for Quality Systems, as required.
• Ensure Quality Systems comply with CGMPs and internal/external regulations and procedures.
• Supports implementation of projects that improve site Quality and efficiency.
• Assess changes in terms of their impact on CGMP and use risk management tools.
• Prepares and compiles the required data to support the APR submission for the products manufactured on-site.
• Management of multiple investigations concurrently
• Provide routine updates to communicate status and alignment on investigation findings.
• Ability to communicate roadblocks and challenges promptly that can impact tasks and timely investigation delivery.
• Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, and Deviations.
• Trains and guides individuals on processing Quality Events, Deviations, and CAPAs effectively and efficiently.
• Holds cross‑functional meetings to discuss root cause analysis of investigations and quality events.
• Track and trend events/deviations
• Develop/author quality SOPs and related documents as needed
• Perform quality review of documentation and processes
• Provide trend reports of quality events
• Ability to convince individuals of the minimum requirements for investigations.
• Excellent Interpersonal skills.
• Decision Making
• Detail Oriented
• Problem Solving/Analysis
• Quality
• Results Driven
• Technical Capacity

Education:

Bachelor of Science (BS) / Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent

Experience:

Minimum three years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry or a…