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Expert - QA Technical OperationsProBio • Pennington, New Jersey, United States
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Expert - QA Technical Operations

ProBio
  • US
    Pennington, New Jersey, United States
  • US
    Pennington, New Jersey, United States
Jetzt Bewerben

Über

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.
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: 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
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.
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  • Pennington, New Jersey, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

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