QA Technical Ops Specialist - GenScript/ProBio
Pennington, NJ
About the Job
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 proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, \ProBio has a stable and high-yield viral vector platform.
Job Scope:
The QA Technical Operations Specialist 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
- Oversee the GMP supplier qualification program and supplier risk management
- Completes the approval requirements to qualify new suppliers including negotiating quality agreements
- Periodic review of suppliers, Identifies 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 CAPA's, 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
Qualifications:
- Bachelor's degree in Science, Engineering, Business, Management or related field (Advance degree a plus)
- 2-3 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.