Validation QA Specialist

PSC Biotech • Pomona, CA

22h • $110,000 - $120,000

About The Position

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.
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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance, Validation, or Validation Document Review within a regulated GMP environment.
• Demonstrated experience reviewing and approving validation documentation.
• Strong knowledge of validation lifecycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and change controls.
• Working knowledge of FDA, EU GMP, and ICH regulatory requirements.
• Experience with deviation management, CAPA, change control, and document management systems.
• Exceptional attention to detail and document review skills.
• Strong written and verbal communication skills.
• Ability to work independently while managing multiple priorities and deadlines.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Perform QA review and approval of validation documentation.
• Ensure validation documents comply with internal procedures, GMP requirements, and applicable regulatory expectations.
• Review validation documentation for accuracy, completeness, traceability, and technical adequacy.
• Identify documentation deficiencies and collaborate with Validation, Engineering, Manufacturing, and Quality teams to resolve issues.
• Provide QA guidance regarding documentation requirements and quality compliance expectations.
• Review and approve quality system records associated with validation activities, including deviations, investigations, CAPAs, and change controls.
• Verify that validation deliverables are properly documented, approved, and maintained in accordance with document control requirements.
• Support audit and inspection readiness by ensuring validation records are complete and readily accessible.
• Participate in internal audits and regulatory inspections as needed.
• Assist with continuous improvement initiatives related to validation documentation and quality systems.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level