Senior QA Operations: Supplier Quality & Compliance Leader

ProBio; Pennington (NJ); Presencial; USD 70 000 - 95 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending accounts

Health savings account

Life insurance

AD&D insurance

Disability coverage

Legal assistance

Pet insurance

Commuter benefits

Well-being programs

Peer recognition

Resumo da oferta

ProBio, a GenScript subsidiary, is a global CDMO offering discovery to GMP services for plasmids, antibodies, and cell & gene therapies. The role leads QA technical operations to ensure compliance with QA standards and supplier quality controls, collaborating with Facilities, Manufacturing, QC, and Validation teams.

The successful candidate will author SOPs, manage GMP supplier qualification, audits, CAPAs, and supplier scorecards while driving continuous improvement and cost of quality, in

Qualificações

• Bachelor’s degree in science, engineering, business, management or related field.
• 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.

Responsabilidades

• Author/Review SOPs
• Oversee the GMP supplier qualification program and supplier risk management
• Complete 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
• 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

Conhecimentos

Interpersonal skills

Communication

Negotiation skills

Team collaboration

Problem solving

Attention to detail

Results oriented

Formação académica

Bachelor’s degree in science/engineering/business/management or related field

Advanced degree a plus

Descrição da oferta de emprego

ProBio, a GenScript subsidiary, is a global CDMO offering discovery to GMP services for plasmids, antibodies, and cell & gene therapies. The role leads QA technical operations to ensure compliance with QA standards and supplier quality controls, collaborating with Facilities, Manufacturing, QC, and Validation teams.

The successful candidate will author SOPs, manage GMP supplier qualification, audits, CAPAs, and supplier scorecards while driving continuous improvement and cost of quality, in