Aseptic Operations Supervisor

2 weeks ago


East Millinocket, Maine, United States Germer International Full time

Aseptic Operations Supervisor

As a key leader at Germer International, the Aseptic Operations Supervisor is responsible for steering the company’s operations with a focus on Aseptic Manufacturing processes, including formulation and filling. This role collaborates extensively with various departments, including Operations, Quality Assurance, Technical Services, Validation, and Finance.

Key Responsibilities:

  • Lead and mentor a diverse team of Aseptic Manufacturing Associates, focusing on recruitment, management, motivation, and professional development.
  • Oversee Aseptic Manufacturing operations across multiple shifts, providing weekend support as necessary.
  • Conduct thorough internal batch record reviews to ensure compliance and accuracy.
  • Assist in the creation and execution of manufacturing procedures and batch records.
  • Manage daily manufacturing activities, including scheduling and inventory management of raw materials and consumables.
  • Provide guidance during component preparation, bulk drug formulation, and aseptic filling processes.
  • Ensure precise documentation of data and completion of batch records as required.
  • Successfully complete gowning and media fill qualification programs for facility compliance.
  • Train staff in various manufacturing tasks, including Component Preparation, Formulation Operations, and Sterile Filling.
  • Operate and maintain production equipment, ensuring optimal performance.
  • Maintain cleanroom environments and ensure compliance with cleanliness standards.
  • Verify that all personnel on shift are adequately trained on relevant procedures and master batch records.
  • Initiate revisions to cGMP procedures and master batch records as necessary.
  • Assist in scheduling and conducting routine maintenance and calibration of production equipment.
  • Engage in client communications, providing updates on project status and addressing any issues that arise.
  • Interface with auditors, including client representatives and regulatory bodies.
  • Review and approve cGMP documentation to support continuous improvement initiatives.
  • Support audits from agencies, customers, and vendors, maintaining a professional demeanor that reflects positively on the company.
  • Perform additional tasks and projects as assigned.

Qualifications:

  • Comprehensive understanding of cGMP, FDA guidelines, and international regulatory standards is essential; experience in aseptic manufacturing of regulated products is highly desirable.
  • Proven ability to lead a team of cGMP associates in a controlled environment.
  • Skilled in identifying and addressing cGMP gaps within a multidisciplinary team.
  • Strong understanding of Quality principles and procedures in pharmaceutical, biopharmaceutical, or biotech manufacturing settings.
  • Exceptional integrity and professionalism in all interactions.
  • Effective communication skills, both written and verbal, with management, staff, and regulatory representatives.
  • Proven track record of managing teams to achieve objectives efficiently.
  • Strong decision-making skills regarding scheduling, resource allocation, and priority management.
  • Proficient in Microsoft Word, Excel, and Outlook.

Join Germer International and contribute to our commitment to excellence in Aseptic Operations.



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