Job DescriptionYour RoleThe Validation QA Specialist is responsible for providing Quality Assurance oversight of validation documentation and ensuring compliance with applicable GMP regulations, company procedures, and quality standards. This role focuses on the review, approval, and management of validation records to ensure documentation is accurate, complete, and inspection-ready. The ideal candidate will have experience supporting validation programs within a regulated pharmaceutical, biotechnology, or medical device environment and possess a strong understanding of quality systems and documentation controls.
- 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.
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.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- 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
The salary bracket for this role is set between $110,000 - $120,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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