What are the responsibilities and job description for the Cleanroom Operations Manager position at Normann Staffing Services?
About the Position:
Normann Staffing Services seeks an accomplished Aseptic Manufacturing Manager to spearhead our aseptic manufacturing team.
Key Responsibilities:
- Direct and motivate Aseptic Manufacturing Associates, emphasizing teamwork and shared goals.
- Support Aseptic Manufacturing operations across all shifts, including weekends as required.
- Carry out internal batch record reviews, adhering strictly to cGMP regulations.
- Develop strong relationships with clients concerning these processes.
- Work closely with team members to create and implement manufacturing procedures and batch records.
- Ensure thorough documentation and completion of batch records as necessary.
- Complete the facility's gowning and media fill qualification program successfully.
- Train staff in diverse manufacturing tasks, such as Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
- Take responsibility for maintaining production equipment, facilitating its efficient use and upkeep.
- Sustain cleanroom environments and guarantee that personnel is adequately trained on applicable procedures and master batch records prior to execution.
- Lead the effort to revise cGMP procedures and master batch records promptly.
- Support the planning and execution of routine maintenance and calibration of production equipment.
- Engage actively in client communications, including issue resolution, schedule creation, and project status updates.
- Build alliances with auditors, encompassing client representatives and regulatory agencies.
- Review and validate cGMP documentation in pursuit of sustained enhancements, incorporating Procedures, Master Batch Records, Standard Work Instructions, Risk Assessment Reports, Training Curricula.
- Collaborate in Agency, customer, and vendor audits as needed.
- Portray professionalism consistently in interactions with colleagues and external partners, reflecting positively on Normann Staffing Services and upholding the organization's core values.
