Supervisor, Quality Control

Responsibilities:

1 Supervises and trains the Quality Inspectors to ensure inspection and testing is executed efficiently and in compliance with CSL procedures and industry regulations. Maintains department schedule to support operational needs. Maintains and manages the stock of supplies within budget.2 Evaluates current test methods for improvement opportunities. Develops new test methods for compliance withupdates to regulations, standards and changes in equipment.3 Assists with validations and qualifications, DOE’s and other activities that determine the systematic suitability of aproduct.4 Monitors and regularly supervises the group to ensure process and procedural adherence. Responsible for annualperformance reviews.5 Processes product complaint investigations to include tracking, evaluation/investigation, probable/root causedetermination and documenting of correction/corrective action assessment.6 Evaluates and assists with deviations and the initiation of Rick / Impact Assessments and required escalationsfor related CAPAs.7 Conducts data analysis and utilizes reporting tools with ability to present data and results in a comprehensive,detailed, and organized fashion.8 Generates daily, weekly, and monthly trending reports as required.9 Provide input to the risk management process for updates to documentation and any pFMEAs.10 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.11 Escalates complaints/product performance issues to Management as required.12 Participates and supports process, policy improvements, and guidance for enhancement projects such as Leanprojects, supporting action items, and the revision of Standard Operating Procedures (SOP’s) and work instructions(WI).13 Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning,assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaintsand resolving problems.14 Perform job-related duties as assigned.JOB SPECIFICATIONSEducation

• Bachelor Degree in a relevant scientific discipline (Biology, Chemistry, etc.) preferred

Experience

• 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. May be required to lead teams without the benefit of a direct reporting relationship

• 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

Additional Comments

• N/A

Working Conditions (physical & mental requirements)

• Sit; use hands to finger, handle, or feel objects, tools, or controls
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl
• Shares information with internal contacts with common desire to reach a solution
• Understands complex problems to collaborate and explore alternative solutions
• Ability to make decisions which have moderate impact on immediate work unit
• Ability to compose letters, outlines, memorandum and basic reports and/or to orally communicate technical information
• Ability to compute, analyze and interpret numerical data for reporting purposes
• Occasionally exposed to hazardous chemicals
• Occasionally required to wear personal protective equipment
• Exposure to moving mechanical parts, vibration and/or moderate noise levels
• Ability to life or carry up to 30 lbs.
• Work in fast paced environment with frequent interruptions

Note: All qualified applicants will receive consideration for employmen