Packaging Group Lead, 2nd Shift

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    "requisitionDescription": "<div><div><p id=\"isPasted\"><strong>Job Summary</strong></p><p>With advanced and specialized packaging knowledge, oversees and manages the daily operation of a packaging line. &nbsp;Performs functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). &nbsp; This role supervises the day-to-day activities of the Operators and provides guidance on tasks that are being performed on the line. &nbsp;Often, this position is involved in the Operator interview process but are not decision makers in terms of hiring decisions, promotions, annual evaluations, etc. &nbsp;This role is recognized as a process expert, and is qualified as a certified trainer and provides training to less senior Operators. &nbsp;Proactively identifies and performs root cause analysis, in conjunction with other operators/technicians, makes recommendations, and aids in implementation. &nbsp;Responsible for the safe and efficient execution of job duties, while ensuring product compliance to established standards. &nbsp;&nbsp;</p><p>Oversees and coordinates packaging lines for single location. &nbsp;May fill in for supervisor as necessary.</p><p><strong>Responsibilities</strong></p><p>Packaging Operations</p><ul><li>Coordinates each Operator&rsquo;s responsibilities during each shift.</li><li>Monitors the packaging process to ensure schedule is met within standards.</li><li>Conducts final audit of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running <u>all</u> packaging equipment across the entire packaging department.</li><li>Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy.&nbsp;</li><li>Accurately reviews BPR&#39;s steps for completeness and accuracy.&nbsp;</li><li>Request components, labels and inserts per the BPR.</li><li>Set up packaging machinery; accurately sets equipment programming according to BPR&#39;s and SOP&#39;s.</li><li>Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines.</li><li>Conduct sampling: Collects samples from each batch and submits to QA for retained samples.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul><p><strong>Equipment Cleaning</strong></p><ul><li>Conducts verification of line/equipment cleaning and documents per SOP.</li><li>Executes procedures used to clean pharmaceutical packaging equipment and facilities.</li><li>Competently conducts Master Cleans and Line Clearances.</li></ul><p><strong>Continuous Improvement</strong></p><ul><li>Captures and reports metrics; troubleshoots downtime in order to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul><p><strong>Issues &amp; Deviations</strong></p><ul><li>Performs defect evaluations and initiates production event logs.</li><li>Identifies, reports, and suggests resolutions for processing related issues.</li><li>Assists in the investigation of unplanned deviations.</li></ul><p><strong>Quality</strong></p><ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul><p><strong>Teamwork and collaboration</strong></p><ul><li>Communicates and coordinates change-overs and other equipment downtime issues to Reliability Technicians.</li><li>Interfaces with supervisor and/or Quality personnel to inform of deviations or other line issues.</li></ul><p><strong>Continuous Training</strong></p><ul><li>Is qualified as a certified trainer and provides training to less senior operators.</li><li>Stays current on SOPs and cGMPs.</li></ul><p><strong>Continuous Safety &amp; Compliance</strong></p><ul><li>Contribute to safety audits.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis. &nbsp;</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li></ul><p><strong>Misc</strong></p><ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul><p><strong>Qualifications</strong></p><ul><li>High school diploma or equivalent.</li><li>Minimum of 3 years of related packaging experience and/or proficiency demonstrated in competencies as required.</li></ul><p><strong>Knowledge</strong></p><ul><li>Thorough knowledge of cGMP regulations and processes.</li><li>Thorough knowledge of manufacturing and packaging operations.</li></ul><p><strong>Skills &amp; Abilities</strong></p><ul><li>Ability to oversee and manage the daily operation of a packaging line.&nbsp;</li><li>Qualified and capable of running <u>all</u> packaging equipment across the entire packaging department.</li><li>Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to conduct final audits of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler.</li><li>Certified Trainer of others.</li><li>Ability to analyze metrics and troubleshoot downtime in conjunction with other specialists.</li><li>Effectively interfaces with Quality and supervisor to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead or participate in Continuous Improvement projects.</li><li>Good communication skills.</li><li>Good attention to detail in order to conduct final audits and reviews.</li><li>Ability to follow both verbal and written instructions including SOP&rsquo;s and Batch Record documentation.</li><li>Ability to accurately and precisely record data and batch information.</li><li>Ability to work in both independent and team environments.</li><li>Proficient in reading and writing English to understand work instructions and document results.</li></ul><p><strong>Physical Requirements</strong></p><ul><li>Must be able to stand for long periods of time (8 or 12 hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul></div></div>\n",
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