Fill-Finish Operations Manager

5 days ago

Oak Park, Michigan, United States Jobot Full time
Job Summary

We are seeking an experienced Fill-Finish Supervisor to oversee the fill-finish operations in our Aseptic Manufacturing Department. The successful candidate will be responsible for ensuring the highest standards of quality control and adherence to regulatory compliance.

Key Responsibilities
  • Oversee and manage all aspects of the fill-finish operations in an aseptic environment, ensuring all activities are carried out in compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
  • Supervise the cleanroom operations, ensuring the environment is maintained to the highest standards to prevent contamination.
  • Manage the labeling process, ensuring accuracy and compliance with regulatory requirements.
  • Responsible for the sterilization process using an autoclave, ensuring the correct procedures are followed to guarantee product safety.
  • Oversee the Quality Control (QC) processes, ensuring all products meet the required standards and specifications.
  • Conduct verification processes to ensure the accuracy and integrity of all manufacturing operations.
  • Write, review, and update technical documents related to the fill-finish operations, including SOPs, validation reports, and other relevant documentation.
  • Lead and manage a team of technicians, providing them with clear direction and support to ensure they can effectively carry out their duties.
  • Continuously monitor and improve the efficiency and effectiveness of the fill-finish operations.
  • Collaborate with other departments to ensure a smooth and efficient manufacturing process.
Requirements
  • Bachelor's degree in a scientific or related field is required.
  • A minimum of 5 years of experience in a fill-finish supervisory role in a GMP-regulated environment.
  • Extensive knowledge and experience in aseptic manufacturing processes, including fill-finish, labeling, and cleanroom operations.
  • Proven experience in operating an autoclave and managing sterilization processes.
  • Strong understanding of Quality Control (QC) processes and standards.
  • Demonstrated experience in verification processes and technical writing.
  • Excellent leadership and team management skills, with the ability to motivate and inspire a team.
  • Strong attention to detail and the ability to make critical decisions under pressure.
  • Excellent written and verbal communication skills.
  • Strong problem-solving skills and the ability to identify and implement process improvements.
  • Proficient in the use of relevant software and technology.
  • Must be flexible and adaptable to changing priorities and able to manage multiple tasks simultaneously.
  • A commitment to maintaining the highest standards of safety, quality, and compliance.

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