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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.
Job Responsibility:
Reviews data generated by the BQA Department
Ensures all department employees follow applicable laboratory SOPs, OSHA regulations and cGMP regulations
Assists Biological Quality Assurance Supervisor in assessing compliance gaps and implementing corrective actions
Ensures employee training is documented and completed in a timely manner
Performs laboratory tests in BQA when necessary
Assists Biological Quality Supervisor in assigning tasks to BQA personnel
Assists Biological Quality Supervisor in collecting monthly departmental metrics and quarterly metric data
Ensures microbiological testing, investigation and documentation is performed in a timely manner
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
Performs and reports investigations for customer complaints
Assists with sample collection, testing, data collection and interpretation for validation protocols and study protocols
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
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