We are seeking an Investigations & Continuous Improvement Coordinator for our Microbial Solutions site located in Charleston, SC.
Technical SME in the manufacture and testing of Microbial Solutions’ product lines, including both LAL& Celsis rapid microbiology. Responsible for designing and executing test batches / testing methods to support manufacturing and continuous improvement initiatives.
The following are the job responsibilities related to the Investigations & Continuous Improvement Coordinator:
• Designs pilot scale batch manufacturing & testing to support root cause investigation, CAPA & continuous improvement initiatives.
• Oversees the manufacture and testing performed by technicians
• Responsible for managing documentation of associated activities
• Prepare reports summarizing work performed, evaluating results, and providing conclusions.
• Oversee new product transfer from R&D team to Manufacturing, including:
• Pilot batch manufacturing
• Stability / equivalency studies
• Development of in-process & QC test methods and specifications
• PPQ batch production
• Change control documentation
• Perform laboratory activities necessary to isolate, frow and maintain bacterial cultures
• Perform microbiological, endotoxin, and ATP analysis utilizing varying instrument platforms
• Responsible for proficiency in all departmental SOPs.
• Responsible for documentation as required by FDA, company policy, and cGMP.
• Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews
• Perform other related duties as assigned.
The following are the minimum qualifications related to the Investigations & Continuous Improvement Coordinator:
• Education: Bachelor’s degree in Microbiology, Master’s preferred.
• Experience: 5+ years related experience in a laboratory or aseptic or sterile production / fill operations.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: none