Quality Assurance Lot Release (QALR) Specialist

Novato, CA | Contract

Post Date: 04/21/2017 Job ID: 11057 Industry: Clinical & Scientific

Bayside Solutions is seeking a Quality Assurance Lot Release (QALR) Specialist to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.  

 

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.

 

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

 

Quality Assurance Lot Release (QALR) Specialist

 

Job Benefits:

 
  • An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.


 

Summary of Responsibilities:
  • Perform QA review of commercial manufacturing-executed batch records and associated documentation for compliance with cGMPs, SOPs, and other company policies and procedures.
  • Receive, control, scan and archive company commercial manufacturing-executed batch records.
  • Review electronic data in Oracle EBS and compare with paper batch records for consumption.
  • Prepare lot history folders for Novato Formulated Bulk Drug Substance (FBDS) lots.
  • Other QA Lot Release duties as assigned.

 

 

Required Qualifications:

 
  • Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field.
  • For Specialist I, 0-2 years of directly related experience in a GMP Quality or Manufacturing environment.

 

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