Quality Assurance Specialist

Position: QA Operation SpecialistLocation: onsite, Lexington, MAPay: $35/hrDuration: 12 months to startPosition Description:Quality Assurance Operations SpecialistManage the organization of quality records for record reviewReview of logbooks and miscellaneous forms for complianceData entry to support record closureDemonstrate a high level of involvement in continuously improving Quality Assurance philosophy and practices to maintain the highest standards.Responsible for adhering to GxP regulations, cGMPs, and company policies.Required Skills:Record ManagementIntake & Archiving recordsReconciling/Organizing the archive roomResponsible for maintaining record data accuracy in AccessData entry and report out to support record closureReview of logbooks and miscellaneous forms for complianceScope owner of department quarterly logbook reconciliation/auditAdherence to domestic and international GMP regulations, cGMPs, and company policiesAble to perform functions by cGMP guidelines. Knowledge of regulatory requirements and procedures for the US and EuropeMust be capable of defining, implementing, and successfully defending sound QA systems' approaches and principles.Desired Skills (not required but candidate will have exposure to these skills in this role):Strong prioritization and delegation skillsAbility to think strategically and tactically, balancing these as workload changesSelf-motivated and driven to accomplish department goals and objectives independentlyPositive outlook and motivation, despite obstaclesUnderstands the needs of critical collaborators and customers and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.

Created: 2024-11-09