Jobs · Management · North Carolina

Filling Line Lead

Guerbet · Raleigh, NC · 3 wk ago
On-siteManagementFull-time

About the role

The Filling Line Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

Responsibilities

  • Oversee day-to-day operation of the filling line, ensuring production targets for volume, quality, and efficiency are met.
  • Assign daily tasks to line operators based on staffing and production requirements.
  • Verify correct materials, components, and documentation before initiating production.
  • Provide on-the-job coaching and training for new and existing employees.
  • Maintain a positive, collaborative team environment that drives strong engagement and high productivity.
  • Support the training and ongoing development of new hires, temporary workers, and current employees.
  • Exhibit initiatives by independently addressing tasks, challenges, and operational needs.
  • Provide performance feedback to assist the Filling Supervisor with employee reviews.
  • Provide timely, accurate communication regarding production delays to supervisors, managers, and other key stakeholders.
  • Ensure all production documentation meets GMP and GDP standards, identifying errors or discrepancies and coordinating timely corrections.
  • Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
  • Ensure high level of safety, quality, and productivity to maintain reliable supply of products to patients.
  • Promptly report and assist in investigation of any contamination events or deviations.
  • Support departmental objectives including improving safety and performance, reducing deviations, and training compliance.
  • Perform other duties as assigned by management.

Requirements

  • High School Diploma, GED, or equivalent required. Associates degree preferred.
  • Minimum of 5 years of work-specific experience as Production Operator or Production Setup Operator in a pharmaceutical manufacturing environment required.
  • Basic computer literacy, including the ability to use word processing software, spreadsheet programs, and electronic mail communication tools required.
  • Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques required.
  • Experience providing leadership, guidance, or oversight to team members in a fast-paced operational setting preferred.
  • Experience navigating SAP or similar ERP systems to support daily operational tasks preferred.

Qualifications

  • Ability to stand and sit for extended amounts of time.
  • Must be able to lift a minimum of 50 lbs.
  • Ability to operate an electric pallet jack.
  • Full clean room gowning, including gloves, mask, and other protective gear when required.

Skills

  • Strong verbal and interpersonal communication skills.
  • Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
  • Strong mathematical aptitude for accurate measurements and calculations.
  • Mental and visual acuity for production of quality products.
  • Highly skilled in problem-solving and diagnostic abilities.
  • Strong initiative and sound decision making.
  • Strong attention to detail in all tasks to ensure accuracy and compliance.
  • Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.

Benefits

As an Equal Opportunity Employer, Guerbet offers continued personal development, a global leader in diagnostic and interventional imaging, and a commitment to diversity, equity, and inclusion.

Pay

Competitive salary provided.

Schedule

Flexible schedule to accommodate the needs of the role and the team.

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