2nd Shift Quality Control Tech

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A Quality Control Technician I is responsible for performing at least two of the following Quality Control focus areas.

• Component Inspection
• Raw Material Inspection Batch Testing
• Stability Testing

In addition to one of the above areas of responsibility, the Quality Control Technician I is expected to be able to perform general quality control activities including, but not limited to:

• Calibration of shared equipment, including pH meters, balances, UV/VIS spectrophotometers, viscometers, etc.
• Reagent preparation
• Assist in the preparation of standard operating procedures
• Ensure all inspection activities are documented according to SOPs, cGMP, and cGDP requirements.
• Participate in laboratory and customer complaint investigations
• Assist in improvement projects within the quality control laboratory
• Assist in maintaining the laboratory facility and equipment and perform housekeeping duties
• Other duties as assigned

• Assist in setting up and maintain the inprocess workflow for component inspection
• Check for upcoming components being received
• Verify correct components were received
• Visually inspect the components per the certificate of analysis, if applicable
• Visually inspect the component for any defects, cracks, chips, etc.
• Perform dimensional inspection as necessary
• Organize the retention of component samples and standards
• Perform supplemental testing or other miscellaneous machinery testing if needed on component to verify integrity
• Record inspection results in CMS and communicate with different departments on component inspection failures
• Work with the customer service and R&D to ensure new product components meet criteria needed to successfully run the product

• Assist in setting up and maintain the inprocess workflow for raw material inspection
• Check for upcoming raw materials being received
• Verify correct raw materials were received using the purchase order and the supplier COA
• Compare raw material to internal standard if applicable
• Label and pull samples as required for internal testing, retains, standards, and third‑party laboratory testing and coordinate third‑party laboratory testing with the Quality Control Administrator
• Perform physical testing as applicable may include appearance, odor, color, pH, viscosity, or specific gravity
• Record inspection results in CMS and communicate with different departments on raw material inspection failures
• Work with the customer service and R&D to ensure new raw materials meet criteria needed to successfully run the product

• Assist in setting up and maintain the inprocess workflow for batch inspection
• Check for upcoming batches requiring testing
• Perform physical testing of batch samples per the product specification sheet testing may include appearance, color, odor, pH, viscosity, specific gravity, and temperature
• Perform pH or color adjustment calculations as needed
• Record inspection results in CMS and communicate with different departments on batch inspection failures
• Organize the retention of batch samples and standards
• Work with R&D and process engineering when batch troubleshooting is required

• Receive, store and pull stability samples on scheduled pull dates, ensure testing occurs in a timely manner
• Assist in drafting stability and compatibility protocols and initiating new stability studies through Coptis
• Manage stability chamber inventory and storage capacity and ensure stability chambers and test instruments are maintained in a calibrated state
• Create stability summary report templates and stability/compatibility reports
• Work with the customer service and R&D teams to ensure stability/compatibility protocols and reports meet customer requirements and adhere to ICH guidelines

• Knowledge and understanding of cGMP requirements
• Strong organizational skills and attention to detail
• Ability to multitask and adjust priorities
• Computer skills/MS Office proficiency
• Good communication skills and an ability to work in a team environment
• Bachelor’s degree in Chemistry, Biology, or other scientific discipline with 12 years of laboratory or related experience
• Associates degree in Chemistry, Biology, or other scientific discipline with 23 years of laboratory or related experience
• High School Diploma, or equivalent, with 35 years of laboratory or related experience

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