Expert - QA Technical Operations

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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