About The Position

The Line Leader will provide guidance to the assigned Line Workers in order to effectively fill finished good products according to GMPs (Good Manufacturing Practices) and production specifications. This role involves leading and guiding the activities of assigned Line Workers, ensuring adherence to all SOPs, GMPs, and company standards and policies. The Line Leader is responsible for training, motivating, and instructing Line Workers on quality control, general packaging procedures, and safety. They will also inspect line areas for safety and cleanliness, manage safety issues to minimize injury risk, and ensure compliant conditions for line start-up, including proper components, approved product, and documentation. Additionally, the role requires ensuring equipment is cleaned and within calibration before runs, auditing lines at startup, and interacting with other departments to resolve production issues. The Line Leader must ensure efficient utilization of equipment, manpower, and materials to minimize downtime, injuries, and waste, and assist in developing more efficient operational methods. Quality assessment of component parts and products is also a key responsibility, along with maintaining good communication with QA and other departments, and reporting deviations to management.

Requirements

  • High School or GED - Required
  • 2 years or more in pharmaceutical packaging or related industry - required
  • 1 year or more of Line Lead or certified training experience - required
  • Work Overtime as required and may include weekends as needed - required
  • Previous pharmaceutical operations experience
  • Gmp & SOP familiarity
  • Previous experience operating pharmaceutical processing equipment, particularly packaging equipment
  • Excellent written skills
  • Must have good verbal communication skills in English
  • Must possess analytical problem solving and trouble shooting skills.
  • Must have the ability to interact with individuals from all levels throughout the organization
  • Must be a motivated self starter, requiring little to no supervision to accomplish their daily tasks
  • Must have the ability to generate reports/response to investigations
  • Must have excellent attention to detail.
  • Must be an excellent “team” player – assisting co-workers when necessary, and providing training and guidance as needed, particularly to new operators.

Nice To Haves

  • Lean Six Sigma training/experience a major plus
  • Lean Six Sigma experience a major plus

Responsibilities

  • Leads and provide guidance for the activities of assigned Line Workers to effectively fill finished good products according to GMPs (Good Manufacturing Practices) and production specifications.
  • Follow all SOPs, GMPs, and company standards and policies.
  • Trains, motivates, counsels & Instructs Line Workers in the areas of quality control, general packaging procedures, and safety issues.
  • Inspects Line areas to ensure safety and cleanliness standards are in accordance with Good Manufacturing Practices.
  • Responsible for safety issues affecting employees, including taking action to minimize risk of injury as needed & reporting them accordingly.
  • Ensures compliant conditions for line start-up to include proper components, approved product, documentation.
  • Ensure all Equipment is cleaned, approved and within calibration prior to a run.
  • Audits each line at startup to ensure all production requirements are in compliance.
  • Interacts with other departments to identify and resolve issues impacting product quality and/or production efficiencies.
  • Reacts quickly to multiple situations involving production
  • Ensures proper utilization of equipment, manpower, and materials to eliminate downtime, injuries, and/or waste.
  • Assists in developing more efficient means to identify equipment limitations, staffing, and materials to better utilize available resources and maximize productivity.
  • Assesses the quality of component parts and products by inspecting appearance, and correctness by using all available information pertaining to the production run.
  • Maintain good relationship/communication with QA & other departments.
  • Report any deviations or work related issues to Group leaders/Supervisor/Manager.

Benefits

  • short-term incentive opportunity, such as a bonus or performance-based award
  • long-term incentive award, such as restricted stock units
  • comprehensive, flexible and competitive benefits program
  • above-market, diverse and robust health and insurance benefits
  • significant 401(k) matching contribution
  • programs that help you enjoy your career alongside life’s many other commitments and opportunities
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