Shift Aviable: 1st: 6:30 am-3:00 pm 2nd: 2:30 pm - 11:00 pm: comes with 10% Shift differential 3rd: 10:30 pm - 7:00 am: Comes with 15% shift differential 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