Staff QA Engineer

Staff QA Engineer

The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance. This senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. Typical work hours are Monday - Friday from 8a - 5p, but the role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions.

Key Responsibilities :

• Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment.
• Provide strategic quality oversight of facility and equipment commissioning and other activities.
• Review and approve : Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports. Validation related deviations and discrepancies. Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports.
• Lead QA support for risk assessment, FMEA, and change controls governing validation related activity.
• Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations.
• Develop and maintain a safety and quality culture.
• Mentor and train junior QAV Engineers.
• Drive continuous improvement initiatives in validation processes.

Qualifications :

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!