Quality Control Technician

Description:

Key Areas of Accountability / Responsibility:

Summary: 

Autonomous accomplishment of work in the laboratory.

Logs incoming production and raw material samples in LIMS for analytical testing.

Prepares samples for internal and external laboratories and customer pre/co-shipment samples, as needed.

Inspects and composites samples received from production to ensure a representative sample is available for laboratory analysis.

Review raw material Certificate of Analysis data to ensure accuracy prior to reporting.

Responsible for cleaning of laboratory glassware.

Maintains retention area for all laboratory samples.

Reviews data to ensure accuracy prior to reporting.

Performs administrative lab tasks, such as updating SOP’s.

Keeps supervisor informed of work status and suggests follow-up action to resolve atypical results and any problems encountered.

Analyzes raw materials, intermediates, stability samples and finished products for required tests by various analytical and instrumental methods.

Performs and documents all work in adherence with cGMP guidelines.

Maintains, calibrates, monitors laboratory equipment (Incubators, Refrigerators, and other lab equipment as required.)

Executes the environmental monitoring program

Performs the microbiological testing for ATP, environmental swabs and allergen swab programs.

Supports tracking non-routine and priority samples to ensure reliability in communications with internal and external customers.

Responsible for monitoring TrackWise Investigations and Deviations to assure they are complete on-time.

Provides support in investigations as required and record results in TrackWise

Perform internal audits as assigned.

Perform special assignments as requested by plant management.

Provides support and backup to the release and rejection of raw materials and finished goods in LIMS and SAP.

Provides support and backup to generating the Certificate of Analysis for finished products and provides to customers as needed.

Provides support and backup to reviewing production potency adjustment reports to ensure accuracy and completeness of batch build.

 

Skills:

Lab Skills Preferred,

Aseptic Techniques required

Great organizational skills required

Attention to details

Lifting required - no more than 50 pounds

Respirator required at times

Education:

High School Diploma, Bachelor's of Science Preferred but not required

Education: Bachelors Degree