Quality Assurance Specialist

Quality Assurance Specialist

BA Research International is a full service pharmaceutical Contract Research Organization. BA provides bioanalytical, statistical, custom synthesis, pre-clinical, clinical and clinical coordination research services to the pharmaceutical industry.  At BA Research, we pride ourselves on our people and the services they provide. BA Research is seeking a Quality Assurance Specialist for the Houston, TX 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

· 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 scienceKnowledge of GLP/GMP regulations Direct exposure to the procedures used in the conduct of non-clinical studiesKnowledge of Microsoft Word and ExcelAbility to multi task efficientlyAbility to be highly organized

 

Qualified candidates should submit a resume and salary history to: ba.research@yahoo.com