Demo

Quality Control Coordinator

Infotree Global Solutions
Frederick, MD Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/6/2025

Job description :

The successful candidate will be responsible for performing utility sampling, environmental monitoring, Bioburden, and endotoxin testing while ensuring compliance with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). This role requires strong analytical skills, adherence to strict timelines, and the ability to work effectively in a team-oriented environment.

Key Responsibilities :

  • Conduct utility sampling and environmental monitoring to ensure compliance with quality standards and regulatory requirements.
  • Perform Bioburden and endotoxin testing to assess microbial contamination levels.
  • Accurately document test results, maintain records, and ensure all documentation meets cGMP requirements.
  • Follow SOPs and laboratory protocols to ensure consistency, accuracy, and compliance in all testing procedures.
  • Analyze and interpret test results, identifying deviations or potential quality concerns, and escalate issues as needed.
  • Collaborate with cross-functional teams, including Quality Assurance and Manufacturing, to support continuous improvement initiatives.
  • Maintain laboratory equipment and ensure instruments are calibrated and functioning properly.
  • Participate in training programs and stay up to date with industry regulations, cGMP standards, and best practices.

Qualifications & Requirements :

  • Bachelor's degree in Biology, Microbiology, Biotechnology, or a related science field is required.
  • Experience in a cGMP-regulated environment is preferred but not required.
  • Strong attention to detail with the ability to identify and resolve discrepancies.
  • Excellent time management skills and the ability to meet deadlines.
  • Strong communication and collaboration skills to work effectively within a team.
  • Critical thinking and problem-solving abilities to troubleshoot and analyze testing outcomes.
  • Flexibility in work hours, as training schedules may be subject to change based on business needs.
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