Laboratory Quality Assurance Technician

2 weeks ago

Marion, North Carolina, United States Randstad Life Sciences US Full time

Position Title: Quality Control Laboratory Technician

Contract Duration: 1 Year

Work Schedule: 12-hour shifts (7:00 PM to 7:00 AM)

Position Overview:

  • Conduct Quality Control assessments in accordance with organizational protocols, including specifications, testing methodologies, Standard Operating Procedures (SOPs), and relevant Pharmacopoeia (USP, EP & JP) standards, ensuring compliance with current regulatory guidelines to support production activities.

Key Responsibilities:

  • Execute analyses per company specifications, testing methods, and SOPs; adhere to applicable regulatory requirements (e.g., cGMP, cGLP, cGDP); and follow all safety protocols pertinent to laboratory operations.
  • Demonstrate proficiency in instrumental analysis utilizing at least three of the following techniques:
  • HPLC, Atomic Absorption, Flame Photometry, ICP-MS, Polarimetry.
  • Prepare and submit comprehensive and timely reports for all laboratory analyses.
  • Prepare and standardize laboratory solutions as required.
  • Maintain proper laboratory cleanliness and organization as dictated by established procedures and Good Laboratory Practices (GLP).
  • Perform analytical testing and the release of raw materials and packaging components as necessary.
  • Conduct all assigned tasks safely and in compliance with testing methods, SOPs, Safety Data Sheet (SDS) protocols, and federal and state regulations (OSHA, EPA, FDA, etc.).
  • Timely and accurately analyze complaint and stability samples; communicate any quality concerns to the laboratory manager or designated personnel.
  • Ensure that analytical results are presented clearly and accurately.

Language Proficiency:

  • Ability to read and comprehend English and Spanish.

Regulatory Knowledge:

  • Fundamental understanding of cGMP principles.

Technical Skills and Qualifications:

  • Proficient in computer applications (Word, Excel, PowerPoint).
  • Experienced with laboratory data management systems such as Empower, Mass Hunter, LIMS, and Electronic Lab Notebooks.
  • Capable of operating laboratory testing instruments.
  • Willingness to work rotating shifts, including weekends and holidays.
  • Adept at interpreting and converting various units of measurement (temperature, pressure, flow, etc.).
  • Strong mathematical skills: ability to perform basic arithmetic operations and calculate percentages using calculators or similar devices.
  • Ability to follow detailed written procedures and verbal instructions effectively.
  • Potential for a temporary-to-permanent employment opportunity based on performance.

Educational Requirements:

  • Bachelor's Degree in Chemistry (mandatory).

Experience Requirements:

  • Minimum of 2 years in a professional analytical chemistry role.

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