QA Specialist Job in Cambridge 02139, Massachusetts US
QA Specialist The Quality Specialist is responsible for independently performing multiple activities in support of Quality initiatives.
Applies technical proficiency and attention to detail in troubleshooting, as well as the ability to interpret and execute test plans,data and documentation review and final disposition with minimal supervision.
Basic understanding of Quality Management Systems as well as pre-inspection readiness for regulatory audits which conforms to FDA, ICH, and other Health Agencies.
Supports product disposition review master and executed Drug Substance, /Drug Product batch records, release and stability data.
Adapts to new work requests with general instruction and guidance
Conducts GMP document review, including certificate of analysis, specifications, NDA/IND documents, methods, protocols, and qualification reports, with minimal guidance
Initiates and assists in investigations, resolving deviations, OOS/OOT and reviews corrective action plans for adequacy per GMP compliance requirements
Dispositions DP/FP batches and archives them in Quality systems
Represents the Quality department on technical quality related issues at assigned project sub-team meetings and assist in reconciliation of issues with CMOs/CROs
Provides detailed documentation of changes to internal or external processes and procedures as necessary (Change Controls)
Supports data trending, and providing metrics as needed with minimal supervision.
Assists with maintenance and organization of internal record keeping to ensure compliance
Participate all assigned GMP training, technical training, career development training to execute technical job responsibilities.
Understanding electronic data systems (LIMS) or electronic documentation systems (Documentum, QUMAS, TrackWise).
Minimum Requirements: Bachelor's degree or equivalent in the Sciences.
5-7 years experience.
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