Quality Assurance Specialist; CLIA

Key Responsibilities:

Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.

Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.

Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.

Review all documentation for adherence to organizational quality standards.

Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.

Provide QA support for change controls, deviations, investigations, CAPA’s and effectiveness checks.

Develop and maintain compliance-related trending metrics and reports.

Provide recommendations for necessary corrections and improvements to quality processes...

Provide oversight of personnel training record management.

Provide QA support of internal and external audits, as assigned.

Review and update Quality Assurance procedures.

Maintain audit forms and QA records.

Other duties as needed.

Qualifications:

Bachelor’s degree in quality assurance or science-related field.

Minimum of 5 years in GxP or equivalent regulatory environment.

Excellent knowledge of GLP and GCP requirements.

Working knowledge of ISO 9001, ISO 17025, and ISO 17034.

Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.

Able to understand published methodology to audit existing test methods and ensure accuracy.

Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.

Experience performing quality process audits and review of deviations and CAPA.

Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).

Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.

Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.

Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.

Background in molecular biology, virology and/or serology is a plus.

Contract research organization (CRO) experience is a plus.

Experience with eQMS (Qualio) is a plus.

Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

• Relocation assistance

Work Location:

In person