Sr. Associate QA

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p><b>Description</b></p><p>Provide tactical support activities to Site Leads across multiple Quality Systems and Processes through the Regional Work Cell Team.</p><p></p><p><b>Key Responsibilities</b></p><ul><li>Batch record archival</li><li>Log LIMS batches</li><li>LIMS sample plan creation/update</li><li>Enter LIMS data</li><li>Certificate of Analysis creation, as necessary</li><li>Enter SAP master data</li><li>Train on required Quality Systems to perform required tasks</li><li>Escalate risks or roadblocks to managementBatch disposition activities</li></ul><p></p><p><b>Authority</b></p><ul><li>Own basic quality record and document content</li><li>Determines situations which require escalation to <span>management           </span></li><li>Works under general direction</li></ul><p></p><p><b>Basic Qualifications</b>:</p><ul><li>Master’s degree OR</li><li>Bachelor’s degree &amp; 2 years of directly related experience OR</li><li>Associate’s degree &amp; 6 years of directly related experience OR</li><li>High school diploma / GED &amp; 8 years of directly related experience</li></ul><p><b>Preferred Qualifications</b>:</p><ul><li>2+ years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Bachelor’s Degree in a Science Field</li><li>cGMP Experience</li><li>Able to successfully manage workload to timelines</li><li>Familiarity with basic project management tools</li><li>Demonstrated ability to consistently deliver on-time, and high-quality results</li><li>Ability to operate in a matrixed or team environment</li><li>Understanding of the applicable <span>manufacturing/testing</span> processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)</li></ul><p></p><p></p><p></p>.