About The Position

The purpose of this position is to verify, through physical, chemical, and/or microbial testing, that representative samples of raw materials, intermediates, batches, finished goods, and washouts meet the required specifications. Based on data ascertained through testing, make accept/reject decisions in line with the customer expectations and the regulatory requirements (FDA cGMP, BRCGS Consumer Products standard, ISO9001 standard).

Requirements

  • Bachelor Science degree in a science related field.
  • Laboratory analytical skills.
  • Apply advanced math skills and use involved problem solving.
  • Must be self-motivated and initiate continuous improvement.
  • Able to read, write and speak English language at the 12th grade (high school) level.

Responsibilities

  • Ensure prompt testing of samples to support throughput of other departments.
  • Perform required analyses (based on the defined test method) on samples of raw materials, intermediates, batches, finished goods, start of run, washouts.
  • Make timely accept/reject decisions, based on the data ascertained through testing, in comparison to the determined specifications.
  • If out-of-specification (OOS) data is found, initiate an OOS investigation.
  • Maintain records to comply with Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs), and Good Laboratory Practices (GLPs).
  • Prior to testing, ensure equipment has been calibrated, standards/reagents are not expired, and equipment is in proper working order.
  • Perform instrument maintenance, calibrations, solutions preparations and standardization.
  • Maintain the QC Analytical Lab in a neat, clean, and orderly state.
  • Prepare lab batches for the determination of prescribed remedial adjustments of plant batches.
  • Inform QC Analytical Lab Supervisor when lab supplies reach the reorder point.
  • Handle hazardous waste as necessary. Training on handling of hazardous waste is required. It is the responsibility of the employee to be aware of and follow all company policies and procedures regarding hazardous waste handling.
  • Communicate concerns in regards to lab practices, operational issues, quality trends, etc to the QC Analytical Lab Supervisor or the QA & Compliance Manager.
  • Perform other duties as required by QC Analytical Lab Supervisor.
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