Job Title: Lab AuditorJob Description

As a Lab Auditor, you will play a critical role in ensuring the quality and compliance of bioanalytical laboratories. You will be responsible for conducting audits of facility areas, study data and reports, in-laboratory activities, equipment maintenance, reagent and solution preparation, and electronic systems. Your primary focus will be on auditing, with occasional travel to external bioanalytical laboratories to perform audits and support programs. You will document audit details, notify management, and prepare summary reports. Experience with ELISA and/or LCMS is preferred.

Responsibilities

• Conduct audits of facility areas.

• Audit study data and reports, including validation and clinical/nonclinical sample analysis.

• Perform in-laboratory activity inspections.

• Enter audit details into Veeva and notify management upon audit issuance and corrective action plan completion.

• Audit equipment maintenance and standardization records.

• Audit reagent and solution preparation and records.

• Audit electronic systems, including maintenance, standardization, and audit trails.

• Perform external audits of bioanalytical laboratories, with travel required.

• Prepare summary reports of external audits and enter audit details into Veeva.

Essential Skills

• Experience in auditing, with approximately 5 years of experience.

• Experience in a research lab, with 2-3 years of relevant experience.

• Knowledge of quality management systems (QMS) and standard operating procedures (SOPs).

• Experience with bioanalytical techniques such as ELISA and/or LCMS.

• Proficiency in data entry and corrective action planning.

• Familiarity with bioanalytical laboratories and quality assurance practices.

Additional Skills & Qualifications

• BS or MS degree is required; a PhD is considered overqualified.

• Experience with Veeva is a plus but training will be provided.

• Strong understanding of bioanalysis and the ability to transition from bench work to auditing.

Work Environment

The work environment includes both lab and office settings. You will use various technologies and equipment to conduct audits. Occasional travel is required for external audits. The role involves detailed documentation and adherence to quality standards.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.