Job Title: QA Validation Specialist
Location: Rensselaer, NY
Experience: 3+ Years
Skills: BMRAMS, BDMS, GMP/GDP, Validation
Industry: Pharma
Job Overview: Client is seeking a QA Validation Specialist to join one of our largest pharmaceutical clients. This role is based onsite 5 days a week in Rensselaer, NY. The individual will be a key member of the Facilities Compliance Team, focusing on documentation and certification of technical adjustments made by onsite vendors.
Key Responsibilities
- Collaborate cross-functionally between the Facilities Compliance Team and Quality Assurance.
- Generate detailed documentation for review with QA.
- Utilize technical understanding of the certification process to justify technical adjustments made by certifiers.
- Confirm calculations from vendors, analyze raw data, and compare data to transcriptions on reports.
- Defend proposed adjustments when challenged by QA.
- Ensure compliance with regulations in a highly regulated environment.
- Maintain high standards of documentation and technical accuracy.
Required Experience And Skills
- Experience: 3+ years of industry experience in areas such as QA, QA validation, validation documentation, technical documentation, validation certification, or cleanroom certification.
- Technical Skills: High proficiency in Microsoft Word and Excel.
- Technical Understanding: Ability to read and understand technical documents.
- Communication: Excellent communication skills, particularly in cross-functional settings.
- Regulatory Experience: Experience in highly regulated environments such as cleanrooms, biotech, or hospitals.
- Certifications: Experience with or around certifications, including cleanroom certification and HIPPA filter involvement.
Preferred Qualifications & Skills
- Systems Knowledge: Experience with BMRAM or BDMS systems.
- Documentation Standards: Understanding or experience with GDP/GMP documentation.
- Bachelor’s degree in a relevant field such as life sciences, engineering, or a related discipline is preferred.
- Relevant certifications in QA validation or cleanroom certification are advantageous.