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The Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Works closely with project teams and stakeholders across the organization, support development and maintenance of computerized system and data integrity PQS subsystems.
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Summary:
The Quality Assurance (QA) Specialist III –
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The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both...