Quality Assurance Specialist

Quality Assurance Specialist

 

Company Background

BA Research International is a full service pharmaceutical Contract Research Organization. BA Research provides bioanalytical, statistical, custom synthesis, pre-clinical, clinical and clinical coordination research services to the pharmaceutical industry. BA Research is seeking a Quality Assurance Specialist for the Houston office.

Responsibilities:

?  Audit bioanalytical data and reports 

?  Conduct in-process inspection, conduct on-site facility inspections, consult with facility personnel and serve as a resource on the interpretation and application of regulations

?  Comply with Quality Assurance related BA Research Standard Operation Procedures

?  Participate and assist with regulatory inspections and sponsor visits as needed

?  Prepare and retain written reports on audits, inspections and disseminate them to management, study directors and appropriate personnel

?  Provide management with reports on quality assurance activities

?  Review facility standard operation procedures for compliance and provide in-put in updating the standard operation procedures

?  Assure that the calibration schedule for equipment is followed

?  Maintain the calibration records in QA

?  Supply Quality Assurance statements for final reports, support computer validation and equipment validation activities, as well as other duties as assigned

 

Qualifications:

 

?  Bachelor?s degree in Biology or related science

?  Knowledge of GLP/GMP regulations

?  Exposure to the procedures used in non-clinical studies

?  Knowledge of Microsoft Word and Excel

 

Qualified candidates should submit a resume to: hr06@baresearchintl.com .