Validation Analyst III

At Altasciences Preclinical Seattle, we're looking for a dedicated Validation Analyst to join our dynamic Validation department. As a key player, you will be involved in the entire lifecycle of computerized system validation, playing a crucial role in planning, execution, and documentation. If you're ready to be part of a team that values innovation, regulatory excellence, and professional growth, this opportunity is tailor-made for you..

What You’ll Do Here

• Implement industry-leading practices and ensure compliance with GLP, 21 CFR Part 11, and corporate policies. Your contributions will be essential to maintaining the highest standards of regulatory compliance.
• Contribute to the development and upkeep of our validation quality management system, including critical components like the Master Computerized Systems List and the Master Validation Schedule. Your meticulous approach will ensure the accuracy and completeness of our documentation.
• Take the reins on projects, orchestrating resources, managing tasks, and delivering progress reports. Your leadership will be integral to ensuring the smooth execution of validation initiatives.
• Generate and maintain an array of validation deliverables that are pivotal for successful computerized system validation activities. Your attention to detail will play a pivotal role in our validation success.
• Monitor the execution of test plans, acceptance criteria, and test results, ensuring that our computerized systems are operating at their peak performance.
• Collaborate with vendors to ensure the successful implementation of computerized system validation services. Your coordination will contribute to the seamless integration of external expertise.
• Maintain comprehensive inventories, lists, and status updates for approved validation documentation, system configurations, and change controls.
• Ensure adherence to change management procedures for validated systems, playing a key role in maintaining the integrity of our processes.
• Conduct technical assessments on change control and system usage SOPs to ensure compliance and assess impact.
• Respond to internal and external audit findings and actively contribute to corrective actions.

What You’ll Need to Succeed

• 2+ years of computerized system validation experience within the GLP/GMP regulated environment (i.e., 21 CFR Part 11 and 58). Good procedural and technical documentation skills.
• B.S./M.S. degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training
• Proficient in the use of MS Office (Word, Excel, Visio, PowerPoint) and project management tools.
• Exhibit excellent written and verbal communication skills, allowing you to effectively engage with multidisciplinary project teams and stakeholders. Demonstrate a solid understanding of applied mathematics in the life sciences industry, encompassing advanced algebra, regression analysis, and statistics.
  

What We Offer:

The pay range estimated for this position is $75,510 to $105,000. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. 

Benefits
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program #LI-BK1