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QC Support Analyst 2 - 1st Shift

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

 

Position Summary:

Provide laboratory support for execution and process of routine tests for raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory. Participate in and support projects that enhance quality support in key department processes.

 

Responsibilities:

  • Responsible for receipt of samples submitted for testing in the laboratory.
  • May support routine testing as assigned by management. Documents all test results in compliance with procedures and GDP requirements.
  • May assist with LIMS data entry to support product testing, LIMS maintenance and validation activities as assigned by management.
  • Participate in and support of the stability program.
  • Participate in and support with improvement projects.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Maintains personal training file.
  • Assist with maintaining laboratory scheduling for raw materials, intermediates, environmental samples, finished goods, and stability samples.
  • Assist 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 Device/Diagnostics Industry. The QC Support Analyst 2 is in a key position providing support on different projects defined by the QC department. The projects can be related to: microbiology laboratory, biochemistry laboratory, environmental monitoring, LIMS system, stability process program and/or document control.

 

Studies and Experience:

  • BS with 2 years of relevant experience preferred.
  • High school diploma/GED with a minimum of ≥ 6 years of progressively responsible experience or an Associate’s Degree with a minimum of ≥ 4 years of progressively responsible experience working in a regulated, GMP environment required.
  • Industrial experience preferred
  • Experience and scientific knowledge working with relevant microbiology laboratory techniques and quality principles (GMP/GLP).
  • Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.

 

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.
  • Ability to assess safety and environmental risks to ensure tasks adhere to HSE Management System
  • Teamwork orientation. 
  • Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
  • Ability to wear PPE correctly most of the day.

 

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