Quality Operations Visual Inspector - Tier I

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    "description_html": "<p>&nbsp;&nbsp;</p><p><strong>Job Purpose:&nbsp;</strong></p><p>• Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations</p><p>• Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records.&nbsp;</p><p>• Promotes teamwork both within the QA Team and other departments.&nbsp;</p><p>• Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations.&nbsp;</p><p>• Keep line and work station clean and orderly.&nbsp;</p><p>• Perform line clearance including equipment, components and label verification.</p><p>• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor.&nbsp;</p><p>• Specific expertise, skills and knowledge within quality assurance gained through education and experience.&nbsp;</p><p>• The ability and willingness to change direction and focus to meet shifting organizational and business demands.&nbsp;</p><p>• Able to handle diversity of projects.</p><p>• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.&nbsp;</p><p>• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.&nbsp;</p><p>&nbsp;</p><p><strong>Essential Duties and Responsibilities:</strong></p><p>• Monitors and performs finished product attribute inspections.&nbsp;</p><p>• Performs visual inspections of Outsourcing products if deemed necessary or required.</p><p>• Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc.</p><p>• Maintains quality documentation and review to ensure completion and compliance.</p><p>• Promotes teamwork both within the QA Team and other departments.</p><p>• Keep line and work station clean and orderly.</p><p>• Ensure that there is no cross contamination.</p><p>• Perform line clearances.&nbsp;</p><p>• Support validation and manufacturing studies including special sampling and testing.&nbsp;</p><p>• Organize workload during lot changeovers for efficient execution.</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 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.</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>Supplemental Functions:</strong></p><ul><li>&nbsp;Copying, filing, and scanning of documents.&nbsp;</li><li>Performs other similar duties as required.</li><li>Assist in other activities (as needed) for Quality Assurance management&nbsp;</li></ul><p>&nbsp;&nbsp;</p><p><strong>Knowledge &amp; Skills: </strong>&nbsp;</p><p>• Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred.</p><p>• Good written, oral and comprehensive communication skills.&nbsp;</p><p>• Strong understanding of document control procedures, standards, and best practices</p><p>• Detail oriented.</p><p>• Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills.</p><p>• Good visual acuity and observation skills.</p><p>• Good written, oral and comprehensive communication skills.</p><p>• Able to handle diversity of projects.</p><p>• Specific expertise, skills and knowledge within quality assurance gained through education and experience.</p><p>• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.</p><p>• The ability and willingness to change direction and focus to meet shifting organizational and business demands.</p><p>• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.&nbsp;</p><p>• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.</p><p>• Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.</p>",
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      "description": "<p>Description</p><p>  </p><p><strong>Job Purpose: </strong></p><p>• Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations</p><p>• Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records. </p><p>• Promotes teamwork both within the QA Team and other departments. </p><p>• Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations. </p><p>• Keep line and work station clean and orderly. </p><p>• Perform line clearance including equipment, components and label verification.</p><p>• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor. </p><p>• Specific expertise, skills and knowledge within quality assurance gained through education and experience. </p><p>• The ability and willingness to change direction and focus to meet shifting organizational and business demands. </p><p>• Able to handle diversity of projects.</p><p>• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. </p><p>• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. </p><p> </p><p><strong>Essential Duties and Responsibilities:</strong></p><p>• Monitors and performs finished product attribute inspections. </p><p>• Performs visual inspections of Outsourcing products if deemed necessary or required.</p><p>• Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc.</p><p>• Maintains quality documentation and review to ensure completion and compliance.</p><p>• Promotes teamwork both within the QA Team and other departments.</p><p>• Keep line and work station clean and orderly.</p><p>• Ensure that there is no cross contamination.</p><p>• Perform line clearances. </p><p>• Support validation and manufacturing studies including special sampling and testing. </p><p>• Organize workload during lot changeovers for efficient execution.</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. 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