Expert - QA Technical Operations

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

About ProBio

ProBio, a subsidiary of GenScript, has a one stop biopharmaceutical R&D and production platform, mainly dedicated to cell and gene therapy (CGT) drugs, vaccine and biopharmaceutical discovery, antibody protein Provides end-to-end CDMO services from target development to commercial production. GenScript has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers. Since October 2017, it has assisted customers in the United States, Europe, Asia Pacific and other regions to obtain more than 50 IND approvals.

The Expert of QA Technical Operations will be responsible for

• Interpreting, building upon, and complying with company quality assurance standards
• Managing daily supplier quality activities and controls
• Supporting the Strategic Supplier Management process to meet quality, delivery, and cost objectives
• Developing and executing strategic plans to improve supplier quality, delivery, and costs
• Overseeing inbound material release process
• Champion quality assurance procedures, tools, and techniques

Roles and Responsibilities

Author/Review SOPs

Oversee the GMP supplier qualification program and supplier risk management

Completes the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reports

Periodic review of suppliers and identification of supplier compliance issues

Manages vendor complaints

Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk

Liaison between Supplier and QA representatives in addressing the quality concerns from the supply chain

Monitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of Quality

Ensures effective and timely investigation and closure of all CAPAs, supplier non conformances, complaints, and product issues

Development and maintenance of measurement systems for quality costs, indicators, trends and supplier rating

Collects data and compiling supplier scorecards

Manages audit schedule and executes supplier audits

Generates specifications for materials and consumables

Responsible for disposition of materials and consumables

Approve calibration reports for GMP equipment

Support QA Validation in review of SOPs

May interface with auditors during regulatory inspections

Works closely with Facilities, QA Validation, Manufacturing, and QC teams

Travel expectations: < 10%

Qualification

Bachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)

3-5+ years of experience in Quality, Manufacturing, Engineering, or related field

Results oriented, driven individual

Excellent interpersonal, communication and negotiation skills

Strong organizational and problem-solving abilities

High attention to detail and accuracy

Ability to work collaboratively in a team environment

The estimated pay range for the role is between $70,000 - $95,000 based on qualifications and experience.

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GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.