[ref. j9292524] GMP Quality Assurance Analytical Sr. Quality Specialist (Contract)

The senior specialist will focus on change control - events, deviations, and CAPA management. Lab experience - analytical HPLC, data review and biologics experience helpful.

Key Duties and Responsibilities:

• Provides QA review of the GMP data in support of stability and release of clinical products
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Supports analytical method validation, verification, and transfer activities for clinical products
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Supports change control assessment, implementation, and closure; assesses and approves change controls
• Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. Approves investigations/CAPAs
• Supports generations and maintenance of Quality Metrics to support process improvement activities, as necessary
• Represents QA Analytical on cross-functional teams as an experienced Quality technical resource
• Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs as necessary
• Assists in preparation of audit responses as necessary
• Support continuous improvement projects; may facilitate improvement efforts

Knowledge and Skills:

• Working knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing
• Working knowledge of basic analytical techniques in a QC setting (examples, HPLC, Dissolution, GC, KF, NMR, XRPD, PSD, Water Activity, Compendial Methods)
• Experience in assessing Change Controls
• Experience in leading and managing Event Investigations, Root Cause Analysis (RCA), and monitor CAPA implementation
• Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
• Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• Experience working with CMO/CTO’s
• Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
• Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement
• Strong communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences

Requirements

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• 2-4 years of experience, or the equivalent combination of education and experience
• Facilitation/ problem solving /organizational, planning
• Advance knowledge of GMP regulations and applicability to duties.
• Operational QA experience in analytical and/or manufacturing setting, interpretation, and application of cGMPs and applicable guidelines/guidance’s (example: ICH, USP).
• RCA tools/methodology/ technical writing