Experience with SM LIMS (data reporting management system, laboratory information system)
Experience with system validation, specifically SM LIMS (system validation)
Quality Assurance oversight and record management, specifically deviations, corrective/preventive actions and effectiveness verifications (ownership of documentation, data entry verification)
Proficiency in Excel, Word, and Power Point
Strong interpersonal skills
Job Details: Will assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry
Responsible for SM LIMS data coordination activities, including sample reconciliation and CoA generation.
Responsible for management of SM LIMS approval based tasks; aligned to source documentation.
Responsible for supporting validation activities for SM LIMS and associated quality document management.
Responsible for data queries from QC’s electronic systems.
Responsible for QC Assessor for Change Controls impacting analytical systems.
Provides ownership and QA oversight for document management of various processes within QC.
Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
Supports inspection readiness activities across Quality Control, and site audits and inspections.
Maintains project plan commitments supporting critical projects
Supports Continual Improvement initiatives, programs and projects.