Laboratory Systems Technician I

Job Description

Job Description

Title: Laboratory Systems Technician

Job Overview:

This position is primarily responsible for reviewing product documentation and verifying laboratory testing. This is an ideal position for an individual with a background in science, laboratory testing in a cGMP/GLP environment, who has an eye for details and likes the idea of being quality assurance for quality control and in so doing assist BioSpectra in ensuring the efficient operation of the Laboratory Services department.

Key Responsibilities:

• Product Testing Documentation and Verification Review: Responsible for reviewing basic product documentation and verifying laboratory testing. This includes:

1. Water testing
2. Auto-titration
3. Raw material testing

• Logbook and Daily Task Verification: Performs logbook review and verification of daily tasks.
• Instrument Audit Review: Performs an instrument audit trail review for laboratory instrumentation:
  1. UC/Vis
  2. Auto-titration
  3. UATR/IR
  4. Endotoxins
• Project Support: Provides support on projects involving data collection and entry, and verification.
• Document Maintenance: Files laboratory documentation in an organized manner.
• Training: Assists in maintaining training on new procedures and updates to existing procedures.
• Investigations: Assists in generating root causes, performance of root cause analysis and investigative procedures for out of trend or out of specification results.

Skills & Qualifications:

• Education : Bachelor's degree in Science or related field, and/or commensurate relevant experience.
• Experience :
  1. A minimum of one to three years of experience in a quality control and/or cGMP laboratory.
  2. Experience in the pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations is preferred.
• Skills & Capabilities : The ideal candidate will have demonstrated the following abilities:
• o Must be knowledge of cGMP and/or ICH guidance.
• o Must be knowledgeable and have prior experience with preparing cGMP documentation.
• o Must be able to read, write, speak and understand English.