BQA Technical Specialist - Transfusion and Transplant

Werfen•Norcross, GA

About The Position

We are looking for a Biological Quality Assurance (BQA) Technician III to join our QA team. The Biological Quality Assurance Technician III is responsible for Performing a variety of tasks and functions associated with the appropriate day-to-day operations of the Technical Specialist division within the Quality Laboratories. Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. This includes but not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, environmental monitoring and any other task associated with making sure the products reach the customers. Assist with review and approving of test data, trending environmental monitoring data, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time. Biological Quality Assurance Technical Specialist – QA - Healthcare

Requirements

Bachelor’s degree/Science (BS/BA) from four-year college or university; or equivalent combination of education and experience.
1+ years’ experience in a highly Regulated/GMP environment
3-4 years of experience in Environmental Microbiological laboratory setting including experience in laboratory techniques

Responsibilities

Reviews data generated by the BQA Department.
Ensures all department employees follow applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
Assists Biological Quality Assurance Supervisor in assessing compliance gaps and implementing corrective actions as needed.
Ensures employee training is documented and completed in a timely manner and that appropriate records of training and evaluation are maintained.
Performs laboratory tests in BQA when necessary.
Assists Biological Quality Supervisor in assigning tasks to BQA personnel based on priorities defined by the Production Schedule.
Assists Biological Quality Supervisor in collecting monthly departmental metrics and quarterly metric data for Quality review or management review meetings.
Ensures microbiological testing, investigation and documentation is performed in a timely manner to support investigations.
Performs data entry of test results into database.
Performs and interprets calculations as needed.
Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
Performs and reports investigations for customer complaints.
Assists with sample collection, testing, data collection and interpretation for validation protocols and study protocols as assigned.
Follows aseptic technique in controlled areas.
Initiates and completes assigned technical projects.
Initiates and completes technical reports.
Performs other duties as assigned by the BQA Supervisor or Director.