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Quality Control Analyst

2 months ago

Piscataway, New Jersey, United States GenScript Full time

Job Overview:

We are seeking a skilled individual with expertise in quality assurance to support the operational department in managing incoming materials, conducting on-site quality assessments, analyzing quality data, and overseeing product release processes. A solid understanding of quality management principles, familiarity with production workflows, and strong communication and coordination abilities are essential for this position. Experience in biotechnology or quality systems is highly desirable, as this role will involve close collaboration with both the production and backend support teams.

Primary Duties:

  • Develop and uphold a comprehensive quality management framework, ensuring effective implementation and adherence.
  • Oversee the release processes for raw materials and finished products.
  • Identify and address on-site issues or potential risks through regular monitoring, facilitating prompt resolution to enhance quality management standards.
  • Engage in the investigation and resolution of product complaints, returns, and non-conforming products and materials.
  • Manage the collection and statistical analysis of quality-related data, providing timely feedback and generating regular analytical reports.
  • Monitor deviations, out-of-specification results, change investigations, and confirm corrective and preventive action tracking.
  • Conduct training sessions related to quality assurance.
  • Perform additional quality-related tasks as required.

Requirements:

  • Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, Medicine, or related fields.
  • A minimum of 2 years of experience in production or quality assurance roles, with a solid understanding of quality management.
  • Exceptional verbal and written communication skills.
  • Strong interpersonal and teamwork capabilities necessary for effective collaboration in a team-oriented environment.
  • Ability to manage multiple tasks in a fast-paced setting with shifting priorities.