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
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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
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Supervisory Responsibilities | |
Experience | - Formulation Associate II – Three to four (3-4) years’ experience in a GMP environment performing and using formulation/compounding processes and equipment
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Education | - Formulation Associate II – Bachelors’ 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
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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
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