Supervisor – Quality Control

Supervisor – Quality Control

Requirements

• Bachelor Degree in a relevant scientific discipline (Biology, Chemistry, etc.) preferred
• Three (3)+ year’s supervisory and/or demonstrated leadership experience in Quality Control and sampling in a FDA regulated industry
• Knowledge of test methods, method validation, Good Documentation Practices
• Strong understanding of cGMPs and procedure/process knowledge
• Must be skilled and competent with Microsoft Office, computer knowledge or experience with document control software and enterprise resource planning software
• Strong organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions and shifting priorities in support of changing company objectives
• Strong leadership, written and verbal communication, interpersonal and presentation skills to drive results
• Establish solid working relationships to interface with and support leadership, third parties and other positions and circumstances within the organization
• Excellent customer service orientation with flexibility and adaptability to respond quickly to changes as required by the business operations
• Maintain a professional demeanor and handle confidential information with discretion

Responsibilities

• Supervises and trains the Quality Inspectors to ensure inspection and testing is executed efficiently and in compliance with CSL procedures and industry regulations
• Evaluates current test methods for improvement opportunities
• Develops new test methods for compliance with updates to regulations, standards and changes in equipment
• Assists with validations and qualifications, DOE’s and other activities that determine the systematic suitability of a product
• Monitors and regularly supervises the group to ensure process and procedural adherence
• Responsible for annual performance reviews
• Processes product complaint investigations to include tracking, evaluation/investigation, probable/root cause determination and documenting of correction/corrective action assessment
• Evaluates and assists with deviations and the initiation of Rick / Impact Assessments and required escalations for related CAPAs
• Conducts data analysis and utilizes reporting tools with ability to present data and results in a comprehensive, detailed, and organized fashion
• Generates daily, weekly, and monthly trending reports as required
• Provide input to the risk management process for updates to documentation and any pFMEAs
• Participates or supports as necessary in Key Customer Audits to ensure highest level of total customer satisfaction and may be required to travel to Key Customer facilities
• Escalates complaints/product performance issues to Management as required
• Participates and supports process, policy improvements, and guidance for enhancement projects such as Lean projects, supporting action items, and the revision of Standard Operating Procedures (SOP’s) and work instructions (WI)
• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
• Perform job-related duties as assigned

Preferred Qualifications

No preferred qualifications provided.