Quality Assurance Specialist

5 days ago

Pomona, California, United States PSC Biotech Full time
Overview

PSC Biotech is a leading provider of life sciences services, committed to ensuring the highest standards in health care product development, manufacturing, and distribution. Our global team of experts spans across offices in North America, Europe, Asia, and the Middle East, enabling us to deliver exceptional results for our clients.


About the Role

We are seeking an entry-level Quality Assurance Specialist to join our team. This position will play a key role in supporting system validation and product release processes, ensuring compliance with industry standards and regulatory requirements. As a Quality Assurance Specialist, you will contribute to the development and improvement of validation procedures and drive overall product excellence.


Key Responsibilities
  • Collaborate with cross-functional teams and external clients to ensure alignment on project requirements.
  • Conduct thorough testing to ensure system functionality and reliability, utilizing a risk-based validation approach.
  • Support the planning, development, and implementation of computer systems validation documentation.
  • Write and execute required validation documentation, including requirements specifications, test scripts, summary reports, trace matrices, etc.
  • Initiate and oversee system CSV associated change control requests and associated validation documentation.
  • Identify and troubleshoot any potential risks and effectively implement required solutions.
  • Ensure compliance with industry standards and regulatory requirements.
  • Participate in team meetings and provide updates on projects progress.

Requirements
  • Bachelor's degree in a related engineering discipline.
  • This is an entry-level position. Prior internship or project experience within computer systems/software testing and validation.
  • Basic understanding of validation processes and risk-based approach.
  • Familiar with clinical trial software.
  • Knowledge of the Software Development Cycle is preferred.
  • Excellent technical computer skills.
  • Advanced technical writing skills, and familiar with technical lifecycle documentation in regulated industries.
  • Strong attention to detail with a commitment to quality.
  • Excellent communication and interpersonal skills.
  • Excellent time management skills with the ability to manage multiple projects effectively.

Compensation

The estimated annual salary for this position is $60,000 - $80,000, depending on experience and qualifications. PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and education assistance.


About Us

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment.

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