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 shift (7:00 PM to 7:00 AM)

Position Overview:

  • Conduct Quality Control evaluations in accordance with organizational protocols, including Specifications, Testing Procedures, Standard Operating Procedures (SOPs), and compliance with Pharmacopoeia (USP, EP & JP) standards and current Regulatory guidelines to support production workflows, adhering to directives from supervisors or designated personnel.

Key Responsibilities:

  • Execute analyses following Company Specifications, Testing Procedures, SOPs, and relevant Pharmacopoeia guidelines; ensure compliance with current regulatory standards (e.g., cGMP, cGLP, cGDP, etc.); adhere to all safety protocols applicable to laboratory operations.
  • Demonstrated proficiency in instrumental analysis utilizing at least three of the following techniques:
  • HPLC, Atomic Absorption, Flame Photometry, ICP-MS, Polarimetry.
  • Generate and submit precise and timely analytical reports for all laboratory activities.
  • Prepare and standardize chemical solutions as required.
  • Maintain proper laboratory cleanliness and organization in accordance with established protocols and Good Laboratory Practices (GLP).
  • Perform analytical testing and release of raw materials and packaging components as necessary.
  • Conduct all assigned tasks safely and in compliance with: Testing Procedures and SOP requirements, Safety Data Sheet (SDS) handling and precautions, Federal and state regulations (OSHA, EPA, FDA, EP, etc.), and Company policies.
  • Analyze complaint and stability samples promptly and accurately; report any quality concerns to the laboratory Manager or designated representative.
  • Ensure 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.
  • Able to interpret and convert various units of measurement, including temperature, pressure, flow, area, mass, distance, and volume.
  • Mathematical skills: capable of performing basic arithmetic operations and calculating percentages, as well as using calculators or similar electronic devices.
  • Ability to follow written instructions and verbal directives, and communicate effectively via telephone, fax, or radio.
  • Potential for a temporary-to-permanent employment opportunity based on performance.

Educational Requirements:

  • Bachelor's Degree in Chemistry (Required).

Professional Experience:

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

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