Roles and Responsibilities. Provide QA oversight of aseptic processing. Execute personnel monitoring within the aseptic processing area using MODA system. Execute EM sampling and inspection of finished drug product. Conduct real time review of logbooks, and other associated GMP documents. Support quality investigations. Maintains a high level of understanding of relevant production processes and. quality systems. Collaborates with Formulation Fil...
Business / Data Analyst Responsibilities. Analyze complex requirements by reading STTMs and apply the knowledge to troubleshoot failures in a production environment. Propose solutions to resolve the analyzed problem/issue. Write scripts to correct data (data corrections) and coordinate with the technical team members to ensure the change is delivered to production. Verify changes and certify the data after the data correction is implemented. Arti...
The Administrative Clerk will handle various clerical duties at the plant offices from answering phones, welcoming guests and assisting other office staff, as needed. The ideal candidate for this job is resourceful, a good problem solver and organized. Assuring a steady completion of workload in a timely manner is key to success in this position, along with the ability to multi-task. Candidate will ensure that deadlines are met and work is comple...
Quality Control Analyst responsible for utility sampling, environmental monitoring, Bioburden and endotoxin testing. Analyst responsible for adhering to cGMP guidelines and following SOPs. Analyst will work in team environment and should have good time management and communication skills. Analyst will work M-Thursday first shift (10 hour shifts) for training then will transition to one of the below shifts. Sun-Weds 6AM-4PM. Sun-Weds 7AM-5PM. Sun-...
