Expert - QA Technical Operations

• 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

• →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%

• 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

The estimated pay range for the role is between $70,000 - $95,000 based on qualifications and experience.

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