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Quality Assurance Analyst

2 months ago


Piscataway, New Jersey, United States GenScript Full time
Job Overview

About GenScript

GenScript Biotech Corporation is a prominent global biotechnology organization, established in 2002, with a significant presence across North America, Europe, Greater China, and Asia Pacific. The company operates in four primary sectors leveraging its advanced gene synthesis technology, including Life Science CRO services, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is dedicated to its mission of becoming the most trustworthy biotech firm worldwide, aiming to enhance human and environmental health through innovative biotechnology solutions.

Position Summary:

We are seeking a skilled individual with expertise in quality management to support the business division in areas such as incoming material oversight, on-site quality evaluation, quality data interpretation, and product release procedures. A solid understanding of quality management principles, familiarity with production workflows, and strong communication and coordination abilities are essential for this role. Experience in biotechnology or quality systems is highly desirable, as the candidate will collaborate closely with both the production and backend support teams.

Key Responsibilities:

  • Develop and uphold a quality management framework, overseeing and encouraging its effective implementation.
  • Authorize the release of raw materials and finished products.
  • Identify on-site issues or risks through daily monitoring and ensure prompt resolution through effective communication and coordination to enhance on-site quality management.
  • Engage in the investigation and resolution of product complaints, returns, and substandard products and materials.
  • Collect and analyze quality-related data, providing timely feedback and regular analytical reports on quality metrics.
  • Monitor deviations, out-of-specification (OOS) occurrences, change investigations, and confirm corrective and preventive action (CAPA) tracking.
  • Facilitate quality-related training sessions.
  • Perform other quality-related duties as assigned.

Qualifications:

  • 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-related roles, with a solid understanding of quality management practices.
  • Strong verbal and written communication skills.
  • Excellent interpersonal and teamwork capabilities to function effectively in a collaborative environment.
  • Ability to manage multiple tasks in a dynamic setting with shifting priorities.

GenScript USA Inc. is an equal opportunity employer committed to fostering a diverse and inclusive workforce. The company maintains a drug-free workplace.