Group Leader, Manufacturing

Reposted One Month Ago
Be an Early Applicant
Wilson, NC, USA
In-Office
20-30 Hourly
Senior level
Healthtech • Pharmaceutical
The Role
Supervise 10–20 manufacturing associates in a cGMP environment, ensure adherence to SOPs and batch records, complete SAP transactions and documentation, coordinate cleaning, sampling, maintenance, and cross-department schedules, train staff and maintain training compliance, track production data, support investigations, reconcile batch records, and drive continuous improvement.
Summary Generated by Built In
Job SummaryThe Group Leader provides direct daily guidance to 10-20 associates regarding the day-to-day operations. Ensures department associates adhere to all cGMP and quality standards by following work instruction, standard operating procedures, and batch records.
Hourly Range: $20.49 - $30.21
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

  • Day-to-day direction of 10-20 associates
  • Coordinates scheduling and cleaning by working closely with other departments (quality assurance, chemistry, microbiology, engineering, validation, production planning, etc) and direct manager
  • Proficient at completing all documentation in a timely and cGMP manner
  • Initiates work orders to maintain equipment and facilities
  • Conducts all operations in a safe and compliant manner
  • Trains new and/or existing employees on all aspects of responsibility and continuously trains all personnel on SOP changes. Maintains training compliance for all associates in area of responsibility
  • Coordinates finished goods, cleaning, hold times, etc sampling and delivery to the laboratory
  • Communicates early to supervisor on potential issues that impact scheduling and production
  • Coordinates routine cleaning of all weighing, compounding, filling and associated areas
  • Collects and tracks production data on a daily basis
  • Identifies, coordinates and completes continuous improvement projects in area of responsibility
  • Completes SAP transactions
  • Assists with investigations for area of responsibility
  • Reconciles and reviews batch records
  • Assumes other duties and responsibilities as directed by manager

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Skills Required

  • Operate and enforce cGMP and quality standards
  • Complete batch records, SOPs, and other documentation in a timely, cGMP-compliant manner
  • Lead and provide daily direction to 10-20 associates
  • Train employees and maintain training compliance for area of responsibility
  • Experience completing SAP transactions
  • Coordinate with QA, chemistry, microbiology, engineering, validation, and production planning
  • Initiate work orders and coordinate equipment/facility maintenance
  • Collect, track, and report daily production data
  • Identify and lead continuous improvement projects
  • Assist with investigations and reconcile/review batch records
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The Company
HQ: Bad Homburg v.d.Höhe
21,388 Employees

What We Do

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint

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