QA Compliance Specialist I

                   
                    <p style=”margin: 0px;”><strong><img src=”https://umms.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=114129&hashed=803992340″ alt=”MassBiologics” width=”583″ height=”192″ /></strong></p>
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<p style=”margin: 0px;”><strong>GENERAL SUMMARY OF POSITION: </strong></p>
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<p style=”margin: 0px;”>The QA Compliance Specialist I is responsible for performing a wide variety of activities in order to ensure compliance with applicable regulatory requirements in a cGMP biologics manufacturing facility.</p>                    
                    <p style=”margin: 0px;”><strong>MAJOR RESPONSIBILITIES:</strong></p>
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<li>Reviews batch records, validation protocols, and validation reports; refers issues to senior QA staff.</li>
<li>Reviews completed work orders and calibration reports.</li>
<li>Assists in follow-up on change control documentation and implementation of changes.</li>
<li>Conducts or assists in periodic audits of Manufacturing and Quality Control.</li>
<li>Performs data entry and data analysis as required.</li>
<li>Provides written summaries of excursions from standard operating procedures.</li>
<li>Performs additional job related duties as necessary.</li>
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<p style=”margin: 0px;”><strong>REQUIRED QUALIFICATIONS:</strong></p>
<ul>
<li>Bachelor’s degree with a minimum of 0 – 2 years of relevant experience or equivalent</li>
<li>Ability to follow instructions precisely and recognize excursions from written procedures.</li>
<li>Proficient in MS Word and Excel. Preferred experience in Electronic Document Management Systems.</li>
<li>Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines.</li>
<li>Possesses well-developed attention to detail, ability to maintain accurate records and excellent proofreading skills.</li>
<li>Excellent written and verbal communication skills. Ability to provide basic feedback on compliance documents to all departments within MassBiologics. Ability to communicate effectively (up, down, and laterally) with others.</li>
<li>Demonstrated initiative through past experience</li>
<li>Ability to work effectively both independently and as a member of a team.</li>
<li>Prior experience in a cGMP regulated environment preferred. Strong working knowledge of GMPs and Quality system preferred. </li>
<li>May require travel to the South Coast Manufacturing Facility in Fall River, MA.</li>
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<p style=”margin: 0px;”><strong>SUPERVISION RECEIVED:</strong></p>
<p style=”margin: 0px;”>Under the direction of the QA Manager I or designee</p>
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