Quality Assurance Analyst
1 week ago
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. Our core business revolves around advanced gene synthesis technology, offering services in Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
We are dedicated to our vision of becoming the most dependable biotech firm globally, committed to enhancing human and environmental health through innovative biotechnology solutions.
Position Summary:
We are seeking a skilled professional in quality management to support our business operations with responsibilities including incoming material oversight, on-site quality assessments, quality data analysis, and product release processes. 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 valued, as this position will involve close collaboration with both production and support teams.
Key Responsibilities:
- Develop and uphold a comprehensive quality management system, ensuring its effective implementation.
- Oversee the release processes for raw materials and finished products.
- Identify and address on-site issues and potential risks through regular supervision, facilitating timely resolutions to enhance quality management standards.
- Engage in the investigation and resolution of product complaints, returns, and quality failures.
- Collect and analyze quality-related data, providing timely feedback and regular reports on quality metrics.
- Monitor deviations, out-of-specification results, and track corrective and preventive actions.
- Conduct quality-related training sessions.
- Execute additional quality-related tasks as required.
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.
- Strong verbal and written communication skills.
- Excellent interpersonal skills and the ability to work effectively in a collaborative team environment.
- Capability 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. We uphold a drug-free workplace policy.
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