Quality Assurance Project Leader

2 weeks ago


Durham, North Carolina, United States PSC Biotech Full time
Become a Key Player as a Validation Program Manager

PSC Biotech stands at the forefront of delivering vital services to the life sciences sector, ensuring that the creation, production, and distribution of healthcare products align with regulatory standards. Our worldwide team of specialists is committed to upholding high-quality benchmarks and facilitating our clients' achievements.

Embrace Professional Growth and Excellence

At PSC Biotech, we cultivate a diverse and forward-thinking workplace where you can excel in your career. Being part of our team means collaborating with industry leaders who will guide your professional journey and offer you avenues to refine your expertise.

Your Key Responsibilities

  • Formulate validation strategies, protocols, and documentation for systems and equipment.
  • Oversee project outputs, maintenance scheduling, and risk management.
  • Establish and track key performance indicators for validation success.
  • Collaborate with cross-disciplinary teams and manage project workflows.
  • Review and execute validation documentation effectively.
  • Assist in engineering testing processes while ensuring data accuracy.
  • Recognize potential risks and propose enhancements.
  • Design and improve sterilization processes for pharmaceutical products.
  • Guarantee adherence to regulatory requirements and industry norms.

Qualifications

  • Bachelor's degree in engineering or a related discipline.
  • Over 8 years of experience in validation engineering within the life sciences field.
  • Proficient in technical writing and project management.
  • Familiarity with terminal sterilization methods is advantageous.
  • Willingness to travel for project-related tasks.

Benefits Offered

  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with employer matching.
  • Paid time off, sick leave, and holidays.
  • Support for education and wellness initiatives.

Commitment to Equal Opportunity

PSC Biotech is dedicated to ensuring equal employment opportunities for all individuals based on merit and qualifications related to the job. We advocate for a diverse and inclusive work environment where everyone can thrive.



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