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Quality Assurance Specialist I

2 months ago

Gaithersburg, Maryland, United States LGC Clinical Diagnostics Full time
Job Overview

Company Overview:
LGC Clinical Diagnostics is a leading entity in the life sciences sector, operating under the umbrella of LGC Group. Our facilities are recognized for their compliance with FDA regulations and ISO standards, ensuring the highest quality in clinical diagnostics.

Position Summary:
The Quality Control Analyst I plays a crucial role in supporting manufacturing processes, maintaining laboratory standards, and executing routine sample analyses. This position involves a mix of desk work and hands-on laboratory tasks, including working with biosafety cabinets and chemical hoods.

Key Responsibilities:

  • Assist in product dispensing and kitting operations, which includes:
    • Verifying fill weights and ensuring the integrity of product caps.
    • Checking the accuracy of product labels.
  • Ensure laboratory and equipment are maintained in accordance with established operating procedures.
  • Prepare samples for external laboratory analysis as necessary.
  • Conduct analyses of finished products, intermediate products, and raw materials, adhering to standard operating procedures, which encompass:
    • Immunoassays such as ELISA and Dot Blotting.
    • Nucleic acid extractions and PCR.
    • Wet chemistry analyses including pH and conductivity measurements.
  • Review analytical data for compliance with specifications and document any non-conformances.
  • Compile data and documentation to facilitate product release.
  • Uphold Good Laboratory Practices, ensuring data integrity and traceability.
  • Adhere to company policies and procedures.

Qualifications:

  • Proficient in the use of basic laboratory equipment and techniques, including pipetting and dilution preparation.
  • Ability to analyze and validate results for accuracy.
  • Maintain thorough documentation for traceability purposes.
  • Exercise sound judgment within established practices and policies.
  • Strong written and verbal communication skills, capable of conveying technical information clearly.
  • Ability to work autonomously or collaboratively, depending on the situation.
  • Adaptability to shifting priorities as needed.

Education and Experience:

  • A Bachelor’s degree in a scientific field or equivalent experience is required, along with 1 to 3 years of relevant experience.
  • Hands-on experience with immunoassays is preferred.
  • Experience in a regulated laboratory environment (GLP/GMP) is advantageous.

Physical Requirements:
The physical demands of this role are typical for a laboratory and office environment. Reasonable accommodations may be made for individuals with disabilities to perform essential functions. The work environment may include exposure to biosafety level 2 conditions, necessitating appropriate protective measures.

All personal information will be kept confidential in accordance with EEO guidelines.