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Sr. QA Specialist

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are currently seeking a Senior QA Specialist to support our biopharmaceutical client in the San Mateo, CA area.

Reponsibilities:                                                                                                                                                          

  • Need mid-level (10+ yrs) Sr. Specialist to provide QA oversight for GXP computer systems validation projects (LIMS and Electronic Laboratory Notebook (ELN) System) by conducting the review (including detailed comments/observations) of validation documents and associated discrepancies.
  • Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
  • May attend cross-functional meetings to support the operation of computerized systems.  
  • May participate in the improvement and development of Quality Systems to ensure quality and adherence to cGMPs.

Desired Skills and Experience:

  • Must have biopharmaceutical experience with knowledge of FDA regulations along with application of cGMP and cGDP.                           .
  • Understand industry standards related to validation.
  • Ability to write detailed investigation reports and qualification/validation documents that consistently meet Company and regulatory agency requirements.
  • Verbal and written communication skills. Must be able to read, write, and converse in English.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org

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