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Insight Global QA Validation Specialist in Rensselaer, New York

Job Description

Insight Global is seeking a QA Validation Specialist to join one of our largest Pharmaceutical clients 5x/week onsite in Rensselaer, NY. This individual will be joining the Facilities Compliance Team working to interface cross functionally between their team and Quality Assurance. This person will be working extensively on detailed documentation generation for review with QA. They will be expected to utilize their technical understanding of the certification process to justify technical adjustments made by the certifiers on the team. This team is looking for someone who is detail oriented and passionate about documentation with an understanding of the process and technical aspects of certification. They will be confirming calculations from vendors, analyzing raw data, and comparing said data to transcriptions on reports to defend proposed adjustments when challenged by QA. They will be working cross functionally in a highly regulated environment so an understanding of regulations around documentation as well as excellent communication skills are necessary.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

   

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Skills and Requirements

  • 3+ years of industry experience (QA, QA validation, validation documentation, technical documentation, validation certification, cleanroom certification, etc.)

     - High proficiency in Word and Excel

     - Ability to read and understand technical documents

     - Excellent communication skills (cross functional communication)

     - Experience in highly regulated environments (cleanroom, biotech, hostpitals,

     - Experience with/around certifiers/certifications (Cleanroom certification, HEPA filter involvement) - Experience with BMRAM or BDMS systems

Understanding/experience with GDP/GMP documentation null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.

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