Formulation Technician II, Sun to Wed 6:30 AM to 5PM

Essential Duties and Responsibilities

• Maintains and adheres to safe work habits and all applicable PCI PHARMA SERVICES safety procedures and guidelines
• Owns the daily formulation activities to ensure all scheduled tasks/events are completed
• Performs critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss with minimum to no supervision
• Initiate the production of batch documentation used for engineering and cGMP production
• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
• Completes Batch Records accurately and completely prior to submission to supervision for review
• Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
• Initiate quality system events when these occur within the department
• Cross train in the Fill department to increase technical skills including but not limited to Fill/Cap in room 148
• Able to complete prep work, including operation of autoclave and depyrogenation oven
• Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements
• Complete gowning qualification to perform aseptic operations in the manufacturing area
• Work with enabling groups to improve/implement processes

Qualifications

• High school Diploma, GED, or equivalent credential required; AS degree or BS degree in a STEM field (Science, Technology, Engineering, or Mathematics), such as Computer Science, Engineering, Mathematics, Physics, or a related discipline is preferred
• Minimum 1-3 years’ work experience in a GMP environment preferably in fill finish pharmaceutical operations; equivalent combination of education and experience will be considered
• Experience and knowledge of formulation/compounding tools and equipment
• Demonstrated ability to prioritize multiple projects and activities
• Strong interpersonal skills
• Strong working knowledge of MS Office suite is preferable
• Strong communication skills
• Attention to detail and positive attitude are key attributes
• Able to follow rules and regulations perfectly
• Resilient as well as flexible