Formulation Associate I

Position Summary

Perform all formulation operations in the area of assignment and support start-up/changeovers/tech transfer activities. This position works under the immediate direction of the Formulation Supervisor and all work is conducted following a high standard of GMP compliance and written SOP and batch records.  

Duties and Responsibilities

• Operate glass washers and autoclave, prepare buffers and medias and other solutions 
• Operate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
• Daily completion of formulation activities ensuring all scheduled tasks/events are completed       
• Formulation process steps 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
• Initiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required
• Execute Batch Records accurately and complete prior to submission for review 
• Author process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions
• Cross train to increase technical skills across the department  
• Communicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements
• Other duties as assigned

Regulatory Responsibilities  

• Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements        
• Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

Supervisory Responsibilities

• N/A

Experience

• Formulation Associate I – Zero to two (0-2) years’ experience in a GMP environment performing and using formulation/compounding processes and equipment

Education

• Formulation Associate I – Associates Degree in a science-related discipline or equivalent GMP experience

Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience

Knowledge, Skills & Abilities

• Possess working knowledge of formulation/compounding processes and equipment
• Attention to detail
• cGMP and cGLP practices
• Demonstrated ability to prioritize multiple projects and activities
• Can perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor
• Experience with Microsoft Office and general computer proficiency
• Effective communication and availability
• Able to work effectively with others

Physical Requirements 

• Ability to meet gowning requirements
• Visual acuity
• Fine and gross motor skills to manipulate tools and equipment
• Ability to remain stationary for continuous prolonged periods of time
• Able to lift 30lbs repeatedly
• Able to wear PPE 
• Medically qualified to participate in respirator program
• Use of standard office equipment with or without reasonable accommodation