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Quality Assurance Specialist

San Diego, CA
EmployBridge Search Group is currently recruiting Quality Assurance Specialist in the San Diego California area.  The Quality Assurance Specialist is responsible for document control functions, issuance of controlled documents, updating of SOP binders, maintenance of training records and sending of training notices, assignment of tracking numbers, support for client and regulatory audits, documentation support for client and regulatory audits, and performance of internal audits.


RESPONSIBILITIES
  • Manage change controls for new and revised documents using a document management system. 
  • Management of controlled document binders ensuring that the SOPs are current.
  • Manage training notices and training are completed.
  • Complete training records and procedures are documented in employees’ training files and for audit-readiness.
  • Maintain the schedule and coordinate annual GMP training.  Maintain all appropriate documentation.
  • Coordination of safety training for sessions involving environmental health and safety, fire extinguisher training, evaluation training, etc.
  • Complete Quality Assurance logbooks for the assignment of numbers for deviations, CAPAs, batch records, test methods, equipment, product lot numbers, etc.
  • Provide support locating, inspection, and delivery of the requested documents to the audit room.
  • Notifying staff members when their presence is requested by the client or regulatory agency during audits.
  • Make necessary corrections to document that are identified during the audit.
  • Document necessary information of audits if requested by QA management. 
  • Review calibration certificates for compliance with SOP requirements and equipment specifications.
  • Notify key management and department leaders of all “as-found” calibration failures.  Assignment of investigation numbers and management of the tracking system for completion.
  • Work with QA management in performing internal audits of quality systems and records for GMP laboratories, manufacturing, facilities, and shipping/receiving
 
QUALIFICATIONS
  • Bachelor’s Degree in Chemistry, Biochemistry, Biology, or related science.
  • 3 plus years of quality control, analytical or bioanalytical chemistry experience within a GMP laboratory for a pharmaceutical type industry.
  • Excellent presentation skills both written and verbal.

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