Formulation Associate 3rd shift

SHARP STERILE MANUFACTURING LLC•Lee, MA

49d

About The Position

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.

Requirements

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 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
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

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
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