Specialist , Quality Assurance

Position: Specialist I, Quality Assurance
Preparedness 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 SUMMARY The 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 FUNCTIONS Reasonable 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 challengesSOP generation, review and/or approval

Own quality records (Deviation/CAPA/Change Control).Manage and support the Complaint programAPR 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 management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLSDue to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law.

We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

Bachelor’s Degree in Scientific or related fieldsA 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…