QC Technologist I (C Shift)

5 Minutes ago • 0.5 Years + • Quality Analysis

Job Summary

Job Description

QC Technologist I works in a cGMP environment performing quality control testing for commercial and diagnostics products. Responsibilities include conducting testing of reagents, IVD materials, and personnel swabs. This role involves working with Manufacturing, Technology Transfer, and other departments for data collection and validations for new product QC qualifications, organizing quality controlled materials, and learning new techniques. The position requires performing scientific techniques like spectrophotometry, PCR, and pipetting.
Must have:
  • Perform all work in compliance with company policy and BioFire Diagnostics’ Quality System guidelines.
  • Perform quality control testing on incoming reagents used in Film Array.
  • Maintain supply stocks and coordinate instrument/equipment repairs.
  • Learn new techniques or workflow for new product lines.
  • Responsible for swab set up and reporting for personnel Swab testing program.
  • Perform accurate and efficient QC data entry.
  • Maintain the QC area to ensure it is clean and contamination-free.
  • Coordinate repeat testing.
  • Maintain records as required by the Quality System.
  • Associate’s degree or equivalent education in a life science or related field.
  • Minimum 6 months previous experience in a laboratory setting.
  • Mathematic competency.
  • Excellent attention to details.
  • Ability to accurately follow both written and verbal instruction.
  • Demonstrated proficiency with Microsoft Office Suite.
  • Effective communication skills, both written and verbal.
  • Highly collaborative and team oriented.
  • Demonstrated proficiency with various pipettes.
Good to have:
  • Previous cGMP experience is strongly preferred.

Job Details

Description

QC Technologist I

Shift Schedule: Sunday thru Tuesday from 5:45pm to 6:15am (3x12)

Position Summary

QC Technologist I works in a cGMP environment performing quality control testing for commercial and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing, learning new techniques or workflow as required by new product lines.

This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc.

Primary Duties

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

2. Performs quality control testing on incoming reagents used in Film Array.

3. Maintains supply stocks as well as coordinating instrument/equipment repairs as necessary.

4. Provide support if needed in other projects or validations from various departments within the company.

5. Responsible for learning new techniques or workflow as required for new product lines.

6. Responsible for swab set up and reporting for personnel Swab testing program.

7. Perform accurate and efficient QC data entry.

8. Maintaining the QC area to ensure that it is clean and contamination-free including participation in cleaning and swabbing as assigned.

9. Coordinates repeat testing.

10. Works closely with QC Supervisor and colleagues to ensure consistent and timely turnaround for QC results.

11. Responsible for maintaining records as required by the Quality System.

12. Performs other duties as assigned.

Training and Education

Associate’s degree or equivalent education in a life science or related field.

Experience

1. Minimum 6 months previous experience in a laboratory setting (either academic or professional) is required.

2. Previous cGMP experience is strongly preferred.

Knowledge, Skills, and Abilities

  • Mathematic competency
  • Excellent attention to details
  • Ability to accurately follow both written and verbal instruction
  • Demonstrated proficiency with Microsoft Office Suite
  • Effective communication skills, both written and verbal
  • Highly collaborative and team oriented
  • Demonstrated proficiency with various pipettes is required for this position.

Working Conditions and Physical Requirements

Ability to remain in stationary position, often standing, for prolonged periods.

Ability to ascend/descend stairs, ladders, ramps, and the like.

Ability to wear PPE correctly most of the day.

Ability to operate heavy machinery.

Ability to adjust or move objects up to 25 pounds in all directions.

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