QA Specialist I
<p><span><span><span><span>At </span></span><strong>Kelly® Science, Engineering, Technology & Telecom (SETT)</strong>, we’re passionate about helping you find a job that works for you. How about this one?<br />
<span><span>We’re seeking an <strong>QA <strong><span>Specialist I</span></strong></strong> to work with one of our top global biopharmaceutical clients in the <strong><span>Barceloneta PR</span></strong> area. With us, it’s all about finding the job that’s just right</span></span></span></span><br />
<span><span><strong>Job Description</strong></span></span><br />
<span><span>• Audit and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.</span></span><br />
<span><span>• Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).</span></span><br />
<span><span>• Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.</span></span><br />
<span><span>• Evaluate all deviations documented in batch records and determine the need for a corrective action.</span></span><br />
<span><span>• Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g.
Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.</span></span><br />
<span><span>• Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.</span></span><br />
<span><span>• Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.</span></span><br />
<span><span>• Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product. • Enter required batch information into the lot restriction management system.</span></span><br />
<span><span>• Assemble the batch record review package and label per the approved retention procedures.</span></span><br />
<span><span>• Prepare reports including Right the First Time, Release Cycle Time and Regulatory Audits requests. Revise procedures as required.</span></span><br />
<span><span>• Generate lot lists for the Product Quality Review.</span></span><br />
<span><span>• Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.</span></span><br />
<span><span>• Act as contact person for projects as required.</span></span><br />
<span><span>• Demonstrates accountability and responsibility of EHS performance and compliance.</span></span><br />
<span><span>• Creation and removal of QA Hold condition in SAP system</span></span><br />
<span><span><strong>Requirements</strong></span></span><br />
<span><span>1. Bachelor’s Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering. 2.
Knowledge and experience in manufacturing biotechnology products and GMPs is needed, and in aseptic processing is preferable.</span></span><br />
<span><span>3. Experience working in highly computerized Operations environments– 1 Year</span></span><br />
<span><span>4. Experience working in a Biotechnology Manufacturing Plant in areas of quality, or manufacturing – 2 Years</span></span><br />
<span><span> 5.
The candidate must be proficient in the English language.</span></span><br />
<span><span><strong>Daily Work Schedule Expectations</strong>: Batch Record Review area 1 st or 2nd Shift</span></span><br />
<span><span>Must be Available to any shift, work OT weekends based on business needs</span></span><br />
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<p>10180865</p>