QA Specialist II (Senior) - External Manufacturing, Combination Products & Quality Compliance

 

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I.    JOB SUMMARY 
Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices). 

The role is responsible for (1) QA lead for internal and external projects (2) independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements (3) executing Quality Management System requirements in support of commercial and developmental programs (4) ensuring the realization of industry best practices for GxP and (5) serving as quality approval proxy as required

This position is responsible for performing various functions as an owner, reviewer and/or approver. These functions include deviations, change controls, CAPAs, Complaints, Quality Risk Management validation and transfer protocols reports, trend evaluation and reporting, technical review design of history files (and its supporting documentation), review of critical procedures and processes, lead process changes and new product introduction, assist with regulatory responses, and develop and implement process improvements.  

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
•    Individual will be assigned the responsibility for QA product/client relations and support while working with the client and different teams at the site.  Oversight of quality systems as they relate to the multiple product/client and processes
•    Individual will be liaison between Quality Assurance and other departments to ensure Quality Assurance commitments are completed and to identify areas to improve data trends or process/ product outcomes.  They will operate in a cohesive fashion
•    Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
•    Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination product(s) (devices) at Emergent
•    Responsible for product release, including batch documentation review, management of changes, complaints, deviations, validations, and product annual reviews to ensure completeness, accuracy, and compliance 
•    Lead or assist in continuous improvement projects as assigned. Interacts with senior leadership, direct manager, peers, departmental or non-departmental personnel, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions
•    Perform, review and approve risk assessments and propose risk mitigations and or corrective/preventive actions to reduce process/ product variation as part of the Quality Risk Management program 
•    Lead Implementation of appropriate CAPA or risk mitigations for Quality related items
•    QA oversight of Validation activities including reviewing and approving validation (including Continued Process Verification (CPV)) and stability protocols and reports
•    QA oversight of product related stability activities including new and routine annual requirements
•    Performing review of Design History Files (DHF) for combination products and relevant supporting documentation 
•    Write and implement Quality Plans (where appropriate) to ensure compliance to QMS
•    Trend evaluation and reporting and SPC analysis of trends to determine (when possible) proactive approaches to advert future quality issues with process/ product.
•    Annual product review generation, review and approval
•    Technical review and approval of critical SOPs and processes
•    Coordinate and work with Project Managers and Technical Transfer personnel on process changes and new product introduction
•    Support design and development activities with combination products
•    Quality oversight of Regulatory Affairs activities including with regulatory submissions
•    Developing and implementing process improvements
Other:
•    Participates in and lead Quality Assurance Process Improvement Teams
•    Participates in and lead inspection readiness, audits and regulatory inspections as needed 
•    Provide guidance for ISO 13485 and ISO 14971 requirements for combination products
•    Other assigned responsibilities as established by Mana