What are the responsibilities and job description for the Quality Control Tech position at Phytogenx Incorporated?
A Quality Control Technician I is responsible for performing at least two of the following Quality Control focus areas. Further definition of each focus area can be found on pages 2&3 of this job description.
1) Component Inspection
2) Raw Material Inspection
3) Batch Testing
4) Stability Testing
Role and Responsibilities
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 SOP’s, 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
Component Inspection
- 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 o 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
Raw Material Inspection
- 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 3rd party laboratory testing o Coordinate 3rd 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 o 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
Batch testing
- 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 o 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
Stability Testing
- 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
Qualifications and Education Requirements
- 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
