Sr. Quality Assurance Specialist

Company: EPM Scientific
Location: San Rafael
Posted on: January 11, 2022

Job Description:

A mid-size biotech company is looking for a Quality Assurance Specialist to join their growing team. The client focuses heavily on rare diseases and has an exciting pipeline ranging from phase 1 clinical trials to commercialized products. With multiple candidates in phase 3 and several more in phase 2, their business is in a strong position headed into 2022. You will have the opportunity to cultivate your quality assurance career at a growing sponsor company where quality and continued growth are a key focus.The Quality Assurance Specialist will be responsible for:Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.Support development of commercial and clinical GMP systemsBatch record reviewChange requestsDeviation & CAPA reviewLot releaseWork directly with CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure quality oversight of aforementioned operationsAssist with QA decision, direction, and leadership in assigned interdepartmental meetings.Assist with regulatory inspections.The Quality Assurance Specialist should have the following qualifications:Bachelor's in life sciences or business required2-5 years in life sciences industry related experience2+ year of experience with batch record review and lot dispositionBenefits:Healthcare (Medical, Dental, Vision)Competitive Pay Rate12+ month contract w/ extension and conversion possibilitiesIf you are interested in the Quality Assurance Specialist role, then please don't wait to apply.

Keywords: EPM Scientific, San Rafael , Sr. Quality Assurance Specialist, Other , San Rafael, California