Position: QA Operation Specialist
Location: onsite, Lexington, MA
Pay: $35/hr
Duration: 12 months to start
Position Description:
Quality Assurance Operations Specialist
Manage the organization of quality records for record review
Review of logbooks and miscellaneous forms for compliance
Data entry to support record closure
Demonstrate 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 Management
Intake & Archiving records
Reconciling/Organizing the archive room
Responsible for maintaining record data accuracy in Access
Data entry and report out to support record closure
Review of logbooks and miscellaneous forms for compliance
Scope owner of department quarterly logbook reconciliation/audit
Adherence to domestic and international GMP regulations, cGMPs, and company policies
Able to perform functions by cGMP guidelines. Knowledge of regulatory requirements and procedures for the US and Europe
Must 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 skills
Ability to think strategically and tactically, balancing these as workload changes
Self-motivated and driven to accomplish department goals and objectives independently
Positive outlook and motivation, despite obstacles
Understands the needs of critical collaborators and customers and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
