QA Validation Associate

Reporting to the Director of QA, the QA Validation Associate has a primary focus on the daily execution and compliance of Wheeler validation program. The validation activities include, but not limited to Equipment Qualification and Validation, Temperature mapping / monitoring activities, Computer Software Evaluation and Validation, generation of system requirements for protocol generation and SOP writing, etc. This role requires a meticulous attention to detail, strong leadership capabilities, and a deep understanding of equipment and software validation and associated industry guidance.

Responsibilities:

• Evaluate new equipment and/or software with internal stakeholders to develop and implement user requirements for qualification and/or validation.
• Draft and execute qualification (Installation, Operation and Performance) and validation protocols for equipment and software.
• Conduct equipment and facility mapping and monitoring needs within controlled environments.
• Oversee and facilitate Wheeler’s validation master plan, and support client’s needs for equipment and process validation.
• Support Wheeler’s equipment cleaning needs, verification and validation, as applicable.
• Support and/or lead investigations into quality issues, identify root causes, and implement corrective and preventive actions (CAPAs).
• Manage calibration and validation equipment, to ensure readily available for current and future projects.
• Write SOPs, Company Policies and collaborate with internal team.
• Assist with audits and inspections as needed, from clients and/or Regulatory Representatives.
• Other duties as assigned.

Candidate Required Qualifications:

• Bachelor’s degree in a relevant scientific field or equivalent experience.
• Minimum of 5 years of experience in Engineering, Validation and or other, as applicable in the biotechnology or pharmaceutical industry.
• Familiarity with cGMP and other relevant quality standards and regulatory requirements.
• Excellent communication and organizational skills.

Why Wheeler Bio?

• Opportunity to work with cutting-edge biotechnology in a rapidly growing field.
• Competitive compensation and benefits package.
• Collaborative and inclusive work environment.
• Professional development and growth opportunities.