QA Supervisor-Label Room

Job Functional Area
OPS - Quality
Shift
1st Shift

Overview

The QA Supervisor-Label Room is responsible for management & coordination of all in-process quality assurance analysis for assigned facility in label room department. This role monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. This position is responsible for supervisory management of QA associates on all shifts in the label room and as needed in Quality Org.

Responsibilities

  • Lead and maintain the company's quality inspection and product release programs for in-process materials and components, processes.
  • Continued development of defect training program for quality associates
  • Drive compliance and specification alignment by ongoing authorship in-process QA standard operating procedures (SOPs) and work instructions (WI)
  • Make determinations on actions to prevent reoccurrences utilizing reviews QA data trends
  • Monitors and assesses direct reporting QA staff operating proficiency; Initiate remedial/continuing training as necessary/required
  • Monitors productivity in functional areas and coordinates work schedules and priorities to ensure timely inspection, sampling, and disposition
  • Reports QA Hold on a monthly basis and makes disposition decisions on product physical quality; Reports QA Hold and rejections monthly to QA Management
  • Accountable for the Label Control program
  • Examines programs to create efficiencies in practices and optimal utilization of staff
  • High level involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained 
  • Review of production records for compliance as needed
  • Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised Accountable for meeting functional area goals and objectives as they relate to departmental goals
  • Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives
  • Ensuring procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary
  • Assessing the product specifications of the company and its suppliers, and comparing with customer requirements
  • Setting up and maintaining controls and documentation procedures
  • Maintains proper documentation related to employee performance and timekeeping records, administers employee discipline as appropriate and in coordination with Human Resources
  • Trains quality associates on updated procedures and through annual (minimum) refresher training
  • Resolves QA Holds and determine product disposition through the Rapid Disposition process
  • Reviews Product appearance and Physical Evaluation data sheets to ensure compliance before they are submitted
  • Maintains the equipment calibration and PM program for any equipment
  • Develops and manages QA Budget and orders necessary supplies
  • Ability to function effectively at both strategic and tactical levels
  • Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others
  • Strong change management skills to challenge the status quo and drive improvements
  • High ethical standards
  • Models and supports organization’s goals and values
  • Leadership by example, “roll up the shirtsleeves” management style and work ethic
  • Supervise and lead staff

Qualifications

  • 4 year degree or equivalent experience preferred
  • 5+ years experience in a cGMP regulated or similar manufacturing environment preferred
  • 1+ years experience in a direct supervisory or leadership role preferred
  • Proficient computer skills including electronic mail, word processing, spreadsheets, and graphing (i.e. Microsoft Office Suite, ERP systems and quality-specific software)
  • Knowledgeable of applicable cGMPs requirements
  • Effective communication skills at all levels (i.e. executive and below)
  • Highly organized with strong employee supervisory skills
  • Ability to work independently with little supervision
  • Ability to deal with difficult situations and various departments with tact, professionalism, and discretion and make risk based decisions in a timely manner

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