QO Secondary Packaging Tier I

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    "description_html": "<p>&nbsp;<strong>Job Purpose</strong>&nbsp;</p><p>· Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations.</p><p>· Ensures the accuracy and completeness of batch records.&nbsp;</p><p>Performs other duties as assigned or apparent&nbsp;</p><p>&nbsp;&nbsp;</p><p><strong>Essential Duties and Responsibilities:</strong></p><p>· Review Batch Records and applicable documentation to ensure complete, thorough and accurate data.</p><p>· Responsible for ensuring a high level of employee accountability and performance.</p><p>· Maintains quality assurance documentation including shift pass downs.&nbsp;</p><p>· Keep QA work station clean and orderly.&nbsp;</p><p>· Perform packaging line clearances.</p><p>· Pull Retain, Stability, and Lab samples.</p><p>· Perform or verify Quality Finished Product Attribute Inspections.</p><p>· Perform AQL Calculations.</p><p>· Verify component Exhibits</p><p>· Verify all documents are present within the batch record.</p><p>· Support validation and manufacturing studies, including special sampling and testing.</p><p>· Communicate with Management any quality issues identified with product</p><p>· <strong>Supplemental Functions:</strong></p><p>· Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.</p><p>· Assist with development of solutions for chronic problems within quality assurance</p><p>· Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.</p><p>· Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.</p><p>· Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.</p><p>· Assist in other activities (as needed) for Quality Assurance management.</p><p>&nbsp;&nbsp;</p><p><strong>Job Specifications and Qualifications:</strong></p><p><strong>Skills:</strong></p><ul><li>Detail oriented.&nbsp;</li><li>Technical writing skills required.</li><li>Good written, oral and comprehensive communication skills.&nbsp;</li><li>Operating computer and relevant software;.&nbsp;</li><li>Must be proficient in MS Word, Excel, and PowerPoint;</li></ul><p><strong>Abilities:</strong></p><ul><li>The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;communication; and provides participation, learning, feedback and recognition.&nbsp;</li><li>The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals.&nbsp;</li><li>Ability to handle contending priorities and managing partner expectations</li><li>The ability and willingness to change direction and focus to meet shifting organizational and business demands.&nbsp;</li><li>Assist in other activities (as needed) for Quality Operations management.&nbsp;</li><li>Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.</li><li>Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.&nbsp;</li></ul>",
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