Quality Audit Specialist

About the role

The Quality Audit Specialist role is fully remote and involves executing internal and external audits, supporting vendor and client audits, and driving post-audit actions to completion. This role requires frequent interaction with cross-functional groups and external partners to ensure compliance initiatives are met.

Responsibilities

• Schedule and organize internal and external assessments of LabConnect by QRS or Clients.
• Schedule and perform internal assessments including, but not limited to, computer systems validations, equipment calibration and validation review, internal audits, directed inspections and investigations, gap analyses, etc.
• Schedule and perform external and/or remote assessments of LabConnect critical vendors on a risk-based schedule.
• Update and maintain QRS Key Performance Indicators and other metrics as necessary for assuring timely decision making and updating management.
• Perform document control activities within eQMS including but not limited to SOP creation, revision, obsolescence, approvals.
• Absorb and assist Project Managers and operational management with quality and regulatory advice and assistance when required.
• Track, trend and monitor actions pertaining to audits and compliance activities and other activities in support of the global QMS.
• Compose timely routine correspondence to internal and external stakeholders.
• Organize and maintain electronic and hard-copy file system, and files records as appropriate.
• Independently conduct research and prepare statistical reports.
• Cook up and arrange meetings, prepare agendas, reserve and prepare facilities, and record and transcribe minutes of meetings.
• Perform frequent assessments of quality system for continuous improvement initiatives.
• Train new hires on job specific duties as deemed appropriate.
• Act as QRS representative in internal and external meetings with key stakeholders and/or Clients.
• Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents.
• Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents.
• Utilize Jira to log, monitor, trend, and report quality-related actions, Quality Events, client complaints, audit findings, and CAPAs to ensure timely closure and visibility.
• Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations.

Requirements

Bachelor’s degree with 4-6 years in quality-related roles, specializing in regulatory compliance required. Experience with clinical trials audit activities (hosting audits and conducting audits) is preferred. eQMS software experience is preferred (Veeva Vault is ideal).

Skills and Abilities

• Excellent attention to detail, strong planning, and problem-solving skills.
• Excellent organizational and time management skills.
• Excellent listening and verbal comprehension skills ensuring clarity in professional communication and audit readiness.
• Ability to make well-thought-out decisions and adapt to changing environments and requirements.
• Self-motivation and ability to work well independently as well as using a collaborative team approach.
• Ability to adhere to established timelines, processes, and procedures.
• Ability to work independently and collaboratively, balancing multiple projects with attention to detail.

Physical Demands

• While performing the duties of this job, the occupant is regularly required to: Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus. Use hands and fingers to operate a computer and other office equipment. Walk and/or reach with hands and arms. Read text of various sizes.