Sr. Quality Associate , Quality Assurance

Sr. Quality Associate I, Quality Assurance

Location:

NC-Clayton, US Contract Type:
Regular Full-Time Area: TECHNICAL

The Sr. Quality Associate I Quality Assurance will primarily serve as a Quality Systems technical specialist as part of the QA NFF/NFB business unit. He/She will develop and implement solutions to a variety of quality related objectives to support department goals including executing assignments of medium complexity and developing solutions for defined problems. The Sr. Quality Associate I will also perform manufacturing record review for Pooling through Fractionation Batch Release and other related Quality functions.

Responsibilities:

• Consults with management to develop and implement solutions for achieving quality related objectives.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Uses expertise to make independent decisions within defined areas of responsibility.
• Participates on multi-disciplined project teams.
• Also advances technical project proposals to senior management, following through to successful completion.
• Collects and analyzes data
• Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
• Demonstrated ability to make sound quality decisions with moderate guidance
• Prepares, reviews, and/or approves Incident Tracking System entries and investigation reports
• Demonstrates high levels of values and integrity. Follows cGMP and department safety practices.
• Additional duties may include roles (such as author, reviewer, administrator, or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings and project meetings.

Knowledge, Skills, and Abilities:

• Demonstrated consistent application of technical knowledge and expertise.
• Excellent communication skills (written and verbal) and attention to detail.
• Knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
• Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement.
• Knowledge of fractionation and associated manufacturing processes is a plus, although not required.

Required Experience:

• The successful candidate must demonstrate consistent application of their technical expertise and be able to perform an independent role (such as author and reviewer) for Investigations, CAPA, Change Control, Documentation, Validation, System Impact & Risk Assessments, and Process Improvement.
• Experience supporting Continuous Improvement and Capital Projects including commissioning & validation, system & component impact assessments, risk assessments, process validation, and cleaning validation is also required.

Required Education Sr. Quality Associate I, QA (M08): BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.