What are the responsibilities and job description for the Quality Assurance Validation Lead position at Wheeler Bio, Inc.?
Position Overview: Reporting to the Director of QA, the QA Validation
Lead is the validation SME over the Wheeler Bio validation program. The validation activities include, but are 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.
Key Responsibilities:
Lead is the validation SME over the Wheeler Bio validation program. The validation activities include, but are 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.
Key Responsibilities:
- Evaluate existing and new equipment and/or software with internal stakeholders to develop and implement requirements for qualification and/or validation activities.
- Draft and execute qualifications (Installation, Operation and Performance) and validation protocols for equipment and software (and facility needs, as applicable).
- 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.
Qualifications:
- Bachelor's degree in a relevant scientific field or equivalent experience.
- Minimum of 5-10 years of experience in Engineering, Validation and or other, as applicable in the biotechnology or pharmaceutical industry.
- Project Management and/or Team Leadership / Management is a benefit.
- Familiarity with cGMP and other relevant quality standards and regulatory requirements.