Expert - QA Technical Operations

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

#LW

#PB