Formulation Associate 2nd & 3rd

Job Title

Shift Available:

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 solutionsOperate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipmentDaily completion of formulation activities ensuring all scheduled tasks/events are completedFormulation 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 lossInitiate the production of batch used for engineering and cGMP production and initiate thawing of the API as requiredExecute Batch Records accurately and complete prior to submission for reviewAuthor process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actionsCross train to increase technical skills across the departmentCommunicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvementsOther duties as assigned

Regulatory Responsibilities

Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirementsConduct 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 experienceDegree 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 equipmentAttention to detailcGMP and cGLP practicesDemonstrated ability to prioritize multiple projects and activitiesCan perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation SupervisorExperience with Microsoft Office and general computer proficiencyEffective communication and availabilityAble to work effectively with others

Physical Requirements

Ability to meet gowning requirementsVisual acuityFine and gross motor skills to manipulate tools and equipmentAbility to remain stationary for continuous prolonged periods of timeAble to lift 30lbs repeatedlyAble to wear PPEMedically qualified to participate in respirator programUse of standard office equipment with or without reasonable accommodation