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Quality Assurance Aseptic Specialist
2 months ago
GENERAL PURPOSEReview specifications, procedures, protocols, and batch records for Good Manufacturing Procedures (GMPs) compliance to support finished product releases. Administer and support programs required to ensure certification and continued registration to Safe Quality Food (SQF) standards. Provide support in administration of Standard Operating Procedures (SOP) and hold programs. JOB DUTIES AND RESPONSIBILITIES· Review production and laboratory records for completeness and accuracy in accordance with company and regulatory requirements· Provide finished product releases based on DFA and state regulatory review findings· File and maintain batch production and control records· Inform management of food safety management system conformance to SQF standards through key performance indicators and trend reporting· Maintain employee training records and conduct internal reviews· Collaborate with leadership when non-compliance issues are found. Ensure that supervisors fully explain and document production deviations· Document and update SOPs for facility· Administer SOP program through release to departments that are affected, maintain master SOP binder, verify operating department SOP training documentation, and ensure SOP training is documented annually for all employees· Process hold and disposition system based on leadership instructions. Verify dispositions are carried out and holds are properly documented· Support administrative and quality related studies as assigned by leadership· Adhere to all DFA Quality and Safety policies and procedures and report any nonconformities· Follow all DFA good manufacturing practices (GMP) and work in a manner consistent with all corporate regulatory, food safety, quality, and sanitation requirements· Review product test records: a. Batch testb. Production hourly records2. Monitoring samples that goes into the incubation room a. Make a list of what are expected to be tested in 3 days and 7 days3. Enter 3 days and 7 days results into Aseptic Monitoring Log timely within 24 hours after the test are completed:a. If failure occurs, need to bring up to QA Manager.b. Do a follow up testing· The requirements herein are intended to describe the general nature and level of work performed by employee, but is not a complete list of responsibilities, duties, and skills required. Other duties may be assigned as required