Formulation Associate II

4 months ago

Lee, United States BERKSHIRE STERILE MANUFACTURING LLC Full time
Job DescriptionJob Description

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

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

Supervisory Responsibilities

  • N/A

Experience

  • Formulation Associate II – Three to four (3-4) years’ experience in a GMP environment performing and using formulation/compounding processes and equipment

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

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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