Group Leader, Manufacturing
Fresenius Kabi USA
Summary
The 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.
Job description
Job Summary
The 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.
Responsibilities
- 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
Requirements
- Proficient at completing all documentation in a timely and cGMP manner
- Ability to train new and/or existing employees on all aspects of responsibility and continuously train all personnel on SOP changes
- Maintains training compliance for all associates in area of responsibility
- Ability to coordinate scheduling and cleaning by working closely with other departments
- Ability to collect and track production data on a daily basis
- Ability to complete SAP transactions
- Ability to assist with investigations for area of responsibility
- Ability to reconcile and review batch records
- Conducts all operations in a safe and compliant manner
Benefits
- 401(k) Matching
- Paid Vacation
- Holiday Pay
- Personal Days
- Employee Assistance Program
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Life Insurance
- Disability Insurance
- Wellness Program
Company overview
Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.