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Validation Analyst III

4 months ago

Cypress, United States Altasciences Full time
Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.

At Altasciences Clinical Los Angeles , 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
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences

Other details
  • Job Family T-6
  • Pay Type Salary


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