Senior QA Analyst Supplier
5901 E Lombard St, Baltimore, MD 21224
The Senior QA Analyst, is responsible for supporting Supplier Quality; responsible for tracking/processing of incoming Supplier Notices (Raw Material, Components and Equipment), processing previously received Supplier Notices, contact identified suppliers/vendors, facilitate and lead Supplier Notification site assessments with cross functional SME’ s, evaluate impact of supplier notice as it relates to Raw Materials/components, manufacturing processes, facility, equipment/system or process, assist with the creation/processing of Quality Notifications (Change Controls, Deviations and CAPA’ s), Manage Supplier Notice and Audit documentation, support the creation of Supplier Quality metrics, conduct supplier audits(paper/onsite) as assigned and interact with Global Supplier Quality Center of Excellence as needed. In addition, the Analyst III, QA, will provide support to associated Quality Management Systems. The Quality Analyst III should have a strong technical background in commercial and or clinical biologics/pharmaceutical manufacturing.
The QA Analyst III, will apply expertise and industry knowledge to support change and risk management. They will recommend process improvement solutions to QA manager/team. May interact with, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions as it relates to Supplier Quality.
- Track incoming Supplier Notices
- Conduct QA assessment of Supplier Notices
- Process previously received Supplier Notices
- Lead/Facilitate cross functional team assessment discussions
- Contact suppliers/vendors as needed
- Manage Supplier Notice documentation (electronic/paper files)
- Assess incoming Raw Materials, Component, Facility and Equipment/System Supplier Notices for change impact
- Support Supplier Audits and request for site ordering information
- Work directly with Procurement, QA, Engineering and Facilities, Quality Control, Manufacturing and Manufacturing/Analytical Sciences and Technology
- Support Quality Agreement creation/revisions
- Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA
- Support QA oversight for incoming commercial and clinical projects
- Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
- Support the generation of Supplier Quality metrics
- Initiate Quality Notifications (Deviations, CAPA’ s and Change Controls)
- Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
- Receive assignments in the form of objectives to help achieve department goals
- Support Quality Management systems as assigned (Training, Audits, Document Management, QA Operations)
- Participate in company sponsored training
- Support regulatory and client audits
- Provide Quality input/support to investigations, CAPA’ s and changes
- Support site inspection readiness strategy and activities
- Support internal audits per audit schedule
- BS degree or equivalent level of skill and experience preferred.
- Biologics experience
- A minimum of 5 years related experience.
- Experienced with Supplier Quality; Supplier Notices, Change Controls, leading cross functional teams preferred
- Experienced in application of GMP principles, Minimum of 5 year in an FDA regulated industry.
- Strong computer skills with the Microsoft Office product line.
- Moderate understanding of regulations governing document control and records management.
- Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
- Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
- Strong communication skills: oral/written and listening
- Ability to work individually and in a team environment
- Ability to work under pressure and analyze processes within scheduled timeframes
- Strong presentation skills, including written and verbal communication skills
- Experience in SAP and Technical Writing preferred