Senior QA Specialist (Grand Rapids, MI)

QA Senior Specialist is responsible for providing quality assurance support for the pharmaceutical plant, ensuring all product, process, or system quality activities (from raw material inspection through final product shipment) comply with corporate and governmental regulations.

Responsibilities:
- Develop plans, coordinate, and drive execution of quality projects across multiple site QA areas.
- Coordinate with site QA planners to achieve project deliverables.
- Coordinate with centralized functions to deploy global Pharma 3 initiatives.
- Analyze, manage, and maintain data for cycle times, touch times, and task/process lists to optimize QA performance.
- Develop, improve, and maintain site QA planning and scheduling activities.
- Ensure QA areas under scope implement and maintain visual management tools to monitor key QA processes.
- Analyze and report metrics for planned/unplanned activities; identify risks via early risk assessments and implement mitigation/fallback strategies.
- Lead development of Project Charter and stakeholder requirements; define project objectives and evaluation criteria.
- Support regulatory inspections for new market introduction.
- Lead and/or coordinate compliance and performance improvement projects; provide status to site management.
- Maintain liaison with Quality areas from Third Party Contractors (TPC).
- Based in Grand Rapids at a third-party manufacturing facility.

Qualifications:
- Bachelor’s degree in Business Administration, Sciences, or Engineering.
- 6+ years of quality experience with hands-on Project Management, Scheduling, and Inventory Control.
- Hands-on experience with Excel, Word, PowerPoint, etc.
- Knowledge of statistics desirable.
- Familiarity with GMP and GLP.