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

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.

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

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

N/A

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

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

Possess working knowledge of formulation/compounding processes and equipment

Attention to detailcGMP 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

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 PPEMedically qualified to participate in respirator program

Use of standard office equipment with or without reasonable accommodation