• Experience and knowledge with a variety of root cause analysis tools.
• Demonstrated ability to work with counterparts to accomplish site goals.
• Must be able to manage multiple deliverables, possess excellent organizational skills, be detailed oriented and possess good follow-up skills
• SAP experience preferred
• Vendor management

• Reviews, approves, and provides approval as a quality team member for validation and qualification protocols and reports of pharmaceutical process and equipment to ensure:

• Compliance with cGMP and internal procedures.

The protocols are executed as intended and investigated to resolve any deviations.

Conclusions are accurate based on the results obtained.

• Review of GMP documents including but not limited to Change Control documents, Master Batch Records, SOPs, APRs, specifications, or Laboratory Data.

• Provide quality oversight of the facility and equipment including their calibration through periodic reviews.
• Contributes or leads site initiatives and quality improvement projects, as well as process, facility, utility, and equipment changes.
• Knowledge of and experience with applicable Quality Management Systems
• Assures that systems and processes, in the following areas, are defined and executed in compliance with cGMP and applicable company policy
• Perform other tasks as assigned by Lead or Management

Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.