Specialist I, Quality Assurance

Emergent Biosolutions•Canton, MA

1d•$111,000 - $134,400

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. 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.

Requirements

Bachelor’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 organization

Responsibilities

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.