Quality Control Analyst

<p>The Quality Control (QC) Analyst will work both independently and within a team to perform daily analysis of in-process samples, finished product and raw materials via established test methods while following cGMP and GDP in the QC laboratory.&nbsp; Typical analysis consists of pH, Osmolality, ELISA, PCR, sterility, UV/Vis spectroscopy and other general chemical and bioanalytical assays.</p><p><strong>Principal Responsibilities</strong></p><ul><li>Conducts routine analysis of in-process samples, finished products, and raw materials according to standard operating procedures (SOPs) and Master Specifications.</li><li>Utilizes proper aseptic technique during the execution of analysis.</li><li>Performs stability testing according to established schedules.</li><li>Documents and investigates any OOS results.</li><li>Follows cGMP and GDP to perform all tasks.</li><li>Documents and assesses data against established specifications.</li><li>Perform inventory, stock and clean QC laboratories.</li><li>Perform QC review of data records.</li></ul><p>Department specific/Non-essential responsibilities<strong><strong>:</strong></strong></p><ul><li>Assist with calibrating and maintaining laboratory equipment.</li><li>May perform training of new and existing QC team on established methods and procedures</li><li>May provide technical expertise for method optimization, verification, qualification, and validation.</li><li>May develop and qualify testing methods and SOPs.</li><li>May assist with or lead QC projects for process improvements.</li><li>May draft reports, plans and protocols.</li><li>May revise and updates SOPs.</li><li>Additional duties as assigned.</li></ul>

<p><strong><strong>Experience / Skills:</strong></strong></p><ul><li>Bachelor’s degree in a scientific discipline or equivalent and a minimum of three years’ related experience required.</li><li>Knowledge of cGMP is required.</li><li>Must possess skills and knowledge of general chemical and bioanalytical test methods.</li><li>Knowledge of ELISA, PCR, UV/Vis spectroscopy, cell culture and aseptic technique is preferred.</li></ul><p><strong><strong>Competencies:</strong></strong></p><ul><li>Attention to detail: able to organize and maintain data and information.</li></ul><ul><li>Ability to work in a controlled environment with gowning/PPE requirements.</li><li>Ability to learn through observation and hand’s on experience.</li><li>Ability to work independently in a fast-paced, team oriented organization.</li><li>Strong written and verbal communication skills.</li></ul>