Quality Assurance Specialist

3 weeks ago


lexington, United States Apex Systems Full time

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.



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