Expert - QA Technical Operations
About The Position
ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. 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 the inbound material release process, and championing quality assurance procedures, tools, and techniques.
Requirements
- 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
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
Benefits
- medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- paid parental leave after just three (3) months of employment
- paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
- flexible spending and health savings accounts
- life and AD&D insurance
- short- and long-term disability coverage
- legal assistance
- supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- commuter benefits
- well-being initiatives
- peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
