{"schemaVersion":"jobsearcher.job.v1","id":"e7f8739b0cc3ddeab02f0a72","url":"https://jobsearcher.com/jobs/e7f8739b0cc3ddeab02f0a72","canonicalUrl":"https://jobsearcher.com/jobs/e7f8739b0cc3ddeab02f0a72","title":"Formulation Associate 3rd shift","description":"Position Summary\n\nPerform 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.\n\nDuties and Responsibilities\n\nOperate glass washers and autoclave, prepare buffers and medias and other solutions\nOperate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment\nDaily completion of formulation activities ensuring all scheduled tasks/events are completed\nFormulation 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\nInitiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required\nExecute Batch Records accurately and complete prior to submission for review\nAuthor process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions\nCross train to increase technical skills across the department\nCommunicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements\nOther duties as assigned\n\nRegulatory Responsibilities\n\nComply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements\nConduct 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\n\nSupervisory Responsibilities\n\nN/A\n\nExperience\n\nFormulation Associate I – Zero to two (0-2) years’ experience in a GMP environment performing and using formulation/compounding processes and equipment\n\nEducation\n\nFormulation Associate I – Associates Degree in a science-related discipline or equivalent GMP experience\nDegree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience\n\nKnowledge, Skills & Abilities\n\nPossess working knowledge of formulation/compounding processes and equipment\nAttention to detail\ncGMP and cGLP practices\nDemonstrated ability to prioritize multiple projects and activities\nCan perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor\nExperience with Microsoft Office and general computer proficiency\nEffective communication and availability\nAble to work effectively with others\n\nPhysical Requirements\n\nAbility to meet gowning requirements\nVisual acuity\nFine and gross motor skills to manipulate tools and equipment\nAbility to remain stationary for continuous prolonged periods of time\nAble to lift 30lbs repeatedly\nAble to wear PPE\nMedically qualified to participate in respirator program\nUse of standard office equipment with or without reasonable accommodation","company":"Sharp Sterile Manufacturing","rawCompany":"sharp sterile manufacturing","city":"Lee","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:26:19.371Z","occupations":[{"code":"29-2052.00","title":"Pharmacy Technicians","slug":"pharmacy-technicians"},{"code":"51-9023.00","title":"Mixing and Blending Machine Setters, Operators, and Tenders","slug":"mixing-and-blending-machine-setters-operators-and-tenders"},{"code":"51-9041.00","title":"Extruding, Forming, Pressing, and Compacting Machine Setters, Operators, and Tenders","slug":"extruding-forming-pressing-and-compacting-machine-setters-operators-and-tenders"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325998","title":"All Other Miscellaneous Chemical Product and Preparation Manufacturing","slug":"all-other-miscellaneous-chemical-product-and-preparation-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Formulation Associate 3rd shift","description":"Position Summary\n\nPerform 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.\n\nDuties and Responsibilities\n\nOperate glass washers and autoclave, prepare buffers and medias and other solutions\nOperate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment\nDaily completion of formulation activities ensuring all scheduled tasks/events are completed\nFormulation 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\nInitiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required\nExecute Batch Records accurately and complete prior to submission for review\nAuthor process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions\nCross train to increase technical skills across the department\nCommunicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements\nOther duties as assigned\n\nRegulatory Responsibilities\n\nComply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements\nConduct 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\n\nSupervisory Responsibilities\n\nN/A\n\nExperience\n\nFormulation Associate I – Zero to two (0-2) years’ experience in a GMP environment performing and using formulation/compounding processes and equipment\n\nEducation\n\nFormulation Associate I – Associates Degree in a science-related discipline or equivalent GMP experience\nDegree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience\n\nKnowledge, Skills & Abilities\n\nPossess working knowledge of formulation/compounding processes and equipment\nAttention to detail\ncGMP and cGLP practices\nDemonstrated ability to prioritize multiple projects and activities\nCan perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor\nExperience with Microsoft Office and general computer proficiency\nEffective communication and availability\nAble to work effectively with others\n\nPhysical Requirements\n\nAbility to meet gowning requirements\nVisual acuity\nFine and gross motor skills to manipulate tools and equipment\nAbility to remain stationary for continuous prolonged periods of time\nAble to lift 30lbs repeatedly\nAble to wear PPE\nMedically qualified to participate in respirator program\nUse of standard office equipment with or without reasonable accommodation","datePosted":"2026-04-14T10:26:19.371Z","dateModified":"2026-04-14T10:26:19.371Z","hiringOrganization":{"@type":"Organization","name":"Sharp Sterile Manufacturing","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lee","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e7f8739b0cc3ddeab02f0a72"},"url":"https://jobsearcher.com/jobs/e7f8739b0cc3ddeab02f0a72"}}