Prepare course materials for curriculum. Teach curriculum provided by company to students in China.

Ensure all GMP and GLP, Operations are in compliance. Establish training and audit programs, create, and review of SOPs, investigation, specifications, and Master Manufacturing Records. Provide periodic update on regulatory requirement changes. Responsible for releasing and rejecting of cGMP materials. Manage CAPAs. Perform internal and external audits. Alternate representative when Quality Assurance Manager is out.

Initiating paperwork to request lot numbersCreating the electronic and hardcopy file folders for each batch filePreparing and printing the batch production record from the master production record fileChecking the batch production record for accuracyLogging in the batch production record issuance information into the batch tracking logObtaining the required forms associated with each stage of manufacturingSorting and staging the batch production records and forms for… Show more Initiating paperwork to request lot numbersCreating the electronic and hardcopy file folders for each batch filePreparing and printing the batch production record from the master production record fileChecking the batch production record for accuracyLogging in the batch production record issuance information into the batch tracking logObtaining the required forms associated with each stage of manufacturingSorting and staging the batch production records and forms for autoclaving (as applicable)Distributing the prepared batch production records to manufacturing designatesReconciling cancelled batch production recordsCommunicating status of batch production record issuance with the Supply Chain ManagerProvides Quality Assurance support for Product DevelopmentAssists in creation of Master Batch Records for new productsAssists in the revision of existing Master Batch RecordsVerifies technical information (i.e., equipment ID numbers, SOP references, room number, etc.) in Master Batch Records in accurate vs. cleanrooms.Coordinates and tracks the review and approval of Master Batch RecordsMaintains the Master Batch Record Revision Table Show less

Draft Process Performance Qualification (PPQ) protocol and reports

 Provide support for Product Development, manufacturing activities occurring in classified cleanroom areas for submission batches Perform compliance reviews of temperature monitoring charts, logbooks, notebooks, and records Perform verification of calibration of all Quality Assurance use equipment Perform internal compliance audits Review executed batch production records for batch release Issuance on Master Batch Production Records Provide Quality Assurance for… Show more  Provide support for Product Development, manufacturing activities occurring in classified cleanroom areas for submission batches Perform compliance reviews of temperature monitoring charts, logbooks, notebooks, and records Perform verification of calibration of all Quality Assurance use equipment Perform internal compliance audits Review executed batch production records for batch release Issuance on Master Batch Production Records Provide Quality Assurance for Active Pharmaceuticals Ingredient (API) Synthesis Laboratory Show less

- Perform food safety and quality critical control point checks on process as outlined in the HACCP and Quality Program requirements- Work directly with production staff on testing protocols and requirements to meet and exceed USDA quality and safety requirements- Perform pre-operational inspection on all operating equipment- Monitor production staff’s adherence in meeting product specifications- Monitor proper implementation of other Food Safety and Quality… Show more - Perform food safety and quality critical control point checks on process as outlined in the HACCP and Quality Program requirements- Work directly with production staff on testing protocols and requirements to meet and exceed USDA quality and safety requirements- Perform pre-operational inspection on all operating equipment- Monitor production staff’s adherence in meeting product specifications- Monitor proper implementation of other Food Safety and Quality Programs by performing in process checks, sample collection, and finished product inspection- Assists in data entry for all monitoring and verification activities as required. Prepares reports as necessary to record findings and recommendations for testing.- Monitor shelf life testing for products- Recommended corrective actions to minimize rate of product defects- Train employees on proper standard operating procedures- Verification of nutrition facts and ingredient specifications- Perform aerobic plate counts on raw materials, finish product, and incoming- Perform lactobacillus testing on all incoming products- Perform in-house E. Coli testing on British Retail Consortium) - Calibration of all laboratory equipment- Perform fat analysis on FOSS software- Excellent skills with Bizerba Data Maintenance Software and Bizerba Labeling Design- Perform and create new items set up to met specifications Show less

- Preparation of reports for testing performed- Filing of quality records- Packaging testing- Media preparation- Endotoxin testing of Sarstedt products- Air Sampling