Formulation Associate 2nd & 3rd

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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. &nbsp;</p></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Duties and Responsibilities</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Operate glass washers and autoclave, prepare buffers and medias and other solutions&nbsp;</li><li>Operate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment</li><li>Daily completion of formulation activities ensuring all scheduled tasks/events are completed &nbsp; &nbsp; &nbsp;&nbsp;</li><li>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</li><li>Initiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required</li><li>Execute Batch Records accurately and complete prior to submission for review&nbsp;</li><li>Author process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions</li><li>Cross train to increase technical skills across the department &nbsp;</li><li>Communicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements</li><li>Other duties as assigned</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Regulatory Responsibilities &nbsp;</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements &nbsp; &nbsp; &nbsp; &nbsp;</li><li>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</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Supervisory Responsibilities</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>N/A</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Experience</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Formulation Associate I &ndash; Zero to two (0-2) years&rsquo; experience in a GMP environment performing and using formulation/compounding processes and equipment</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Education</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Formulation Associate I &ndash; Associates Degree in a science-related discipline or equivalent GMP experience</li></ul><p>Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience</p></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Knowledge, Skills &amp; Abilities</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Possess working knowledge of&nbsp;formulation/compounding processes and equipment</li><li>Attention to detail</li><li>cGMP and cGLP practices</li><li>Demonstrated ability to prioritize multiple projects and activities</li><li>Can perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor</li><li>Experience with Microsoft Office and general computer proficiency</li><li>Effective communication and availability</li><li>Able to work effectively with others</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 26.1474%;\"><p><strong>Physical Requirements</strong><strong>&nbsp;</strong></p><p><strong>&nbsp;</strong></p></td><td valign=\"top\" style=\"width: 73.8526%;\"><ul><li>Ability to meet gowning requirements</li><li>Visual acuity</li><li>Fine and gross motor skills to manipulate tools and equipment</li><li>Ability to remain stationary for continuous prolonged periods of time</li><li>Able to lift 30lbs repeatedly</li><li>Able to wear PPE&nbsp;</li><li>Medically qualified to participate in respirator program</li><li>Use of standard office equipment with or without reasonable accommodation</li></ul></td></tr></tbody></table><p><br></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>\n",
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