Specialist I, Quality AssuranceLocation: Canton, MA, US, 02021Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.Job SummaryThe Specialist I, Quality Assurance professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist I will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required.Essential FunctionsReview/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation. Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.) Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges SOP generation, review and/or approval Own quality records (Deviation/CAPA/Change Control). Manage and support the Complaint program APR generation and approval Must be capable to work independently and strategically to ensure day-to-day activities are carried out in support of the business goals Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions. Lead and support additional work as required.Minimum Education, Experience, SkillsBachelor's Degree in Scientific or related fields A minimum of five (5) years of cGMP Quality experience Product and Raw material disposition is a must Well versed in SAP is a must Batch Record review is a must Strong Commercial manufacturing experience (Large Molecules) required Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must Experienced with US, EU pharmaceutical regulations, and ISO standards Expert Knowledge and application of GMP principles Excellent communication skills: oral, written and listening Ability to influence without authority across cross-functional organizationAbout EmergentEmergent prepares those entrusted with protecting their communities against current and future health threats. Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES Lead with Integrity We gain trust and confidence through ethics, quality, and compliance excellence Stand shoulder to shoulder We combine our best thinking and communicate openly to support each other. Own it always We are engaged and accountable for delivering on our commitments. Breakthrough thinking We take smart risks, pursue innovation and challenge ourselves to constantly improve. Compete where it counts We set the right goals and respect each other as we conquer them together.
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