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Specialist II, Quality Assurance

Emergent BioSolutions

This is a Full-time position in Canton, MA posted February 22, 2021.

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.I. JOB SUMMARYThe QA Specialist II 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 Rockville Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II 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.II. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.* Review/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.The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.III. MINIMUM EDUCATION, EXPERIENCE, SKILLSBachelor’s Degree in Scientific or related fieldsA minimum of seven (7) years of cGMP Quality experienceProduct and Raw material disposition is a mustWell versed in SAP is a mustBatch Record review is a mustStrong Commercial manufacturing experience (Large Molecules) requiredExpertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a mustExperienced with US, EU pharmaceutical regulations, and ISO standardsExpert Knowledge and application of GMP principlesExcellent communication skills: oral, written and listeningAbility to influence without authority across cross-functional organizationIV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICSThere are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.ABOUT EMERGENTProtecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.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* Stand shoulder to shoulder no matter what* We combine our best thinking and communicate openly to support each other.* Break through thinking* We take smart risks, pursue innovation and challenge ourselves to constantly improve.* Own it always* Every person at Emergent is engaged and accountable for delivering on our commitments.* Compete where it counts* We set the right goals and respect each other as we conquer them together.