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Quality Assurance Specialist

2 months ago

Scarborough, Maine, United States GForce Life Sciences Full time

Job Type: Contract, 2nd Shift, 2pm-10:30pm

Job Summary:

The Quality Control Technician plays a crucial role in ensuring the quality of products meets the standards set forth by GForce Life Sciences' Quality System and regulatory agencies. This position involves performing testing, troubleshooting technical issues, and maintaining compliance with Good Manufacturing/Laboratory Practices (GMP/GLP).

Key Responsibilities:

  • Product Testing:
  • Conduct thorough testing of in-process components and final release testing for Lateral Flow, ELISA, and Molecular products.
  • Technical Support:
  • Troubleshoot complex technical and quality issues related to testing and production processes.
  • Procedures and Safety:
  • Develop and adhere to new procedures, ensuring proper safety precautions are taken.
  • Perform technical procedures and utilize laboratory equipment effectively.
  • Batch Record Review:
  • Review and ensure accuracy of batch records, maintaining a high level of attention to detail.
  • Equipment Management:
  • Calibrate and maintain laboratory equipment, ensuring optimal performance.
  • Compliance:
  • Maintain strict adherence to Good Manufacturing/Laboratory Practices (GMP/GLP), ensuring regulatory compliance.

Basic Qualifications:

  • Associate's degree in Biology, Chemistry, Life Sciences, or a related technical field, or an equivalent combination of education and experience.
  • At least 1 year of experience in a laboratory and/or quality control setting.

Preferred Qualifications:

  • 2+ years of experience in a regulated industry.
  • 2+ years of experience with GMP, FDA, ISO, and USDA regulations.

Essential Skills and Abilities:

  • Proficiency in performing technical procedures and using laboratory equipment.
  • Strong troubleshooting skills and ability to resolve complex technical and quality issues.
  • Ability to review and ensure the accuracy of batch records.
  • Understanding and adherence to GMP/GLP standards.