Aseptic Sterile Fills Specialist
The main responsibilities will include but not limited to follows:
• Provide hands-on direction for Aseptic/Sterile Fill Finish cGMP manufacturing activities.
• This position requires extensive technical expertise in Aseptic Techniques and Filling. Oversee and schedule compounding and filling operations within cGMP guidelines for Drug Products.
• Experience with Flexicon Automated Fill unit a huge plus.
• Perform Environmental Monitoring for Grade A/B during product fills to EU guidelines.
• Equipment and tubing Assembly preparation related to the filling operation.
• Troubleshoot complex drug product fill problems. Leads the formulation/fill finish tasks. Identify issues and propose adequate solutions.
• Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as it relates to the Fill Finish Operation.
• Oversee the inventory of components and spare parts for the fill machine
• Maintain and foster an environment of safety in the laboratory by becoming trained in and adhering to the safety policies of the laboratory.
• Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
• Foster team building and provide the necessary training to other staff members as required
• Ensure that all processing equipment and instruments are identified, and maintained as per internal approved procedures.
• Communicate and suggest regular process improvement to management
• Work effectively with QA/QC, manufacturing, facilities and other support staff personnel.
• Cross train as needed with the manufacturing team.
Knowledge and Experience Required:
• A minimum of 5 year experience is required with Aseptic/Sterile Fill Finish tasks.
• BS degree in science field, experience may be considered in lieu of a degree.
• Experience in a cGMP environment is required.
• The candidate must have strong and effective interpersonal skills (both written and oral) and ability to communicate effectively with QA/QC, manufacturing, facilities and other support staff.
• Task and Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task is essential
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements