QA Auditor

7 days ago

San Jose, United States PSC Biotech Full time
Job DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are hiring an experienced QA Auditor to support the transition of a new CMO facility. This is a temp role, supporting SOP audits, gap analyses, and staff training.

  • Perform GAP analysis and auditing on all standard operating procedures, making any required updates.
  • Provide quality recommendation regarding GxP processes, environmental monitoring procedures, and as related to clean rooms and utilities.
  • Perform high-level GMP training to staff members within R&D, clinical, and so on.
  • Support the setup and outlining of GMP processes ensuring adherence to industry regulations and compliance.
  • Effectively advise and provide technical guidance in program changes and execution.
  • Additional responsibilities as required.


Requirements
  • Bachelors degree in relevant scientific discipline.
  • 5+ years of quality assurance experience in the pharmaceutical and/or biotech industry.
  • Advanced understanding of cGxP regulations, EU regulations, and industry compliance
  • Experienced in quality auditing and GAP analysis.
  • Excellent attention to detail with proven success in reviewing and editing standard operating procedures.
  • Ability to effectively train team members and foster a collaborative team environment.
  • Excellent communication skills.
  • Anlytical and able to provide technical support and guidance in decision-making and program improvement.

Estimated pay (dependent on experience) $45 - $60 per hour.

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