Senior Specialist, Quality Operations

Role Summary

Senior Specialist, Quality Operations. Oversight of laboratory operations and quality control activities to ensure timely testing, data review, and release of materials in compliance with cGMP, regulatory requirements, and company standards. Focused on continuous improvement within the Quality Laboratory and coordination across manufacturing, contract manufacturers, and suppliers.

Responsibilities

• Completes a variety of testing to support release and stability requirements for a variety of products.
• Supports all areas of the laboratory, cross-training and providing testing support in various work cells as required.
• Provides training to other teammates and serves as subject matter expert.
• Maintains compliance by following corporate policies/guidelines and local procedures.
• Identifies improvements to procedures and revises/trains others on the changes completed. Functions as departmental Change Control Coordinator/Task Owner.
• Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activities.
• Identifies and implements changes focused on improving compliance performance in the laboratory.
• Leads Tier 1 Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell. Actively participates in Tier 2 and Tier 3, as needed.
• Demonstrates in-depth understanding of product performance and testing methodology. Able to train others on both.
• Promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
• Ensures work is completed right first time. Performs root cause analysis and corrective action identification for deviation occurrences and properly documents investigations. Identifies proactive measures to ensure right first-time achievement.
• Leads remediation of walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits.
• Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limits testing, finished pharmaceutical products, and stability samples.
• Interprets compendial and internal monographs, NDAs, CFR and our Company Analytical Standards.
• Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
• Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations.
• Identifies improvement opportunities and, independently or as a facilitator of change, implements improvements. Applies continuous improvement tools (lean six sigma, human error prevention, etc.).
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.
• Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance.
• Provides guidance to new analysts within and outside their cell.
• Performs Purified/Potable Water sampling and testing.
• Performs Compressed Air Utility sampling and testing.
• Performs Environmental Monitoring sampling and testing.
• Supports GLIMS team as necessary.
• Performs Microbial Enumeration Testing per USP.

Education

• At least a Bachelor's degree in science or engineering.

Experience & Skills

• Knowledge of continuous improvement principles
• Minimum of five (5) years of pharmaceutical industry experience
• Technical Writing experience
• Experience with writing SOPs
• Knowledge of federal and industry guidelines and regulations, and dealing with regulatory authorities
• Root cause analysis
• Background in technical writing
• Experience applying 5S concepts
• Experience operating routine laboratory equipment including pH, TOC/CONDUCTIVITY, Biological Safety Cabinets
• Experience with SAP/Trackwise
• Prior supervisory/management experience