What are the responsibilities and job description for the Regulated Product Specialist position at Normann Staffing Services?
About the Opportunity:
Normann Staffing Services is searching for a seasoned Aseptic Manufacturing Manager to assume responsibility for our cleanroom operations.
Key Responsibilities:
- Supervise and mentor Aseptic Manufacturing Associates, fostering a culture of excellence and cooperation.
- Oversee Aseptic Manufacturing operations across all shifts, offering support as needed during weekends.
- Undertake internal batch record reviews, ensuring strict adherence to cGMP standards.
- Develop collaborative relationships with clients concerning these processes.
- Partner with colleagues to create and implement manufacturing procedures and batch records.
- Guarantee accurate documentation and completion of batch records as required.
- Successfully complete the facility's gowning and media fill qualification program.
- Train employees in various manufacturing tasks, including Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
- Manage production equipment, promoting efficient use and upkeep.
- Maintain cleanroom environments and guarantee personnel is adequately trained on relevant procedures and master batch records before execution.
- Drive prompt revision of cGMP procedures and master batch records.
- Support the scheduling and performance of routine maintenance and calibration of production equipment.
- Engage actively in client communications, addressing issues, creating schedules, and providing project status updates.
- Build strong alliances with auditors, encompassing client representatives and regulatory agencies.
- Review and validate cGMP documentation in pursuit of sustained enhancements, covering Procedures, Master Batch Records, Standard Work Instructions, Risk Assessment Reports, Training Curricula.
- Support Agency, customer, and vendor audits as needed.
- Exemplify professionalism in all interactions with colleagues and external partners, reflecting positively on Normann Staffing Services and upholding the organization's core values.
