Compounder

301044 Fresenius Kabi USA, LLC; Tennessee; Vor Ort; USD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Zusammenfassung

Fresenius Kabi USA, LLC is seeking a formulation operator responsible for accurate weighing, checking and verification when mixing chemical compounds for product formulation. You will monitor mixing and ancillary equipment, ensure proper batch documentation, and follow cGMPs and SOPs.

Role requires operating all formulation equipment, using the PCS7 DCS for recipe execution, and maintaining strict material storage conditions.

Qualifikationen

• Experience weighing and verifying chemical blends for formulation.
• Follows cGMP, SOPs and maintains batch records accurately.
• Ability to train new staff and perform sampling and documentation.

Aufgaben

• Performs set-up, operation and monitoring of tanks and mixing equipment.
• Uses PCS7 distributed control system for recipe execution.
• Weighs and mixes precise chemicals and verifies product output.
• Ensures proper storage of raw materials with temperature control.
• Operates formulation equipment (scales, pH meters) and adjusts pH as needed.
• Cleans and sanitizes equipment per SOPs and completes daily/weekly/monthly cleanliness.
• Records batch compounding and material usage accurately; initiates work orders.
• Trains new employees and participates in hold-time studies and sampling.

Kenntnisse

Weighing accuracy

Verification

cGMP compliance

SOP adherence

Documentation

Training

Sampling

Tools

PCS7 DCS

Scales

pH meters

Jobbeschreibung

Job Summary

Responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling. Routinely complies with cGMP's, departmental SOP's and company policies and maintains accurate documentation for each batch manufactured.

Responsibilities

• Performs set-up, operation and monitoring of tanks and mixing equipment for product formulation.
• Including the use of PCS7 distributed control system for recipe execution.
• Weighs out and mixes precise amounts of chemicals according to specific formulas and monitors (verifies) product output from mixing operations.
• Responsible for the correct storage of raw materials (i.e. temperature requirements, nitrogen blanketing and moisture sensitive).
• Operates all formulation-related equipment (such as scales, pH meters, etc.).
• Performs operations necessary to adjust pH of product before releasing to production lines.
• Cleans and sanitizes equipment and chemical containers used in the product formulation process in accordance with SOP's.
• Performs daily, weekly and monthly department cleaning.
• Perform sanitization and operation of the WFI heat exchanger.
• Completes documents accurately when recording batch compounding, consumption of raw materials and cleaning activities.
• Initiates work orders to maintain equipment and facilitates continuous improvement.
• Strictly adheres to SOP's, cGMP's, safety requirements and company policies.
• Assists in the training of new employees and completes training on procedures in scheduled time frame.
• Perform accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development.
• Performs other duties and responsibilities as directed by supervision.

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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

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