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QC Analyst 1

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

 

Position Summary:

Executes routine tests per standard operating procedures.  Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.

 

Responsibilities:

  • Performs routine testing of samples submitted to the laboratory.  Documents all test results in compliance with procedures and GDP requirements. 
  • Enters data into LIMS system.  Assists with LIMS data entry to support LIMS maintenance and validation activities
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements
  • Maintains personal training file
  • Maintains laboratory equipment in compliance with procedures and GLP requirements
  • Assists in the stocking of laboratory supplies
  • Perform any additional job related duties as requested

 

Supplemental Information:

This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 1 will be in a key position in the biochemistry laboratory performing testing of Description, pH, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. 

 

Studies and Experience:

  • BS with 0  years of relevant experience preferred.
  • High school diploma/GED with a minimum of ≥ 4 years of progressively responsible experience or an Associate’s Degree with a minimum of ≥ 2 years of progressively  responsible experience working in a regulated, GMP environment required.

 

Skills and Qualifications:

  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
  • Excellent and effective verbal and written communication skills.
  • Theoretical knowledge of relevant laboratory techniques and quality principles.
  • Knowledge of software tools for data entry and analysis.
  • Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
  • Teamwork orientation.
  • Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
  • Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.
  •  Ability to wear PPE correctly most of the day.

 

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