Regulatory Compliance and Laboratory Quality Consultant

Key Role:

Maintain responsibility for the promotion of regulatory compliance and quality awareness and continuous improvement throughout the organization by coordinating activities across the stakeholders while providing assistance with the implementation and improvement of quality management and regulatory compliance processes and systems. Manage stakeholder expectations by establishing open communication with leadership and ensure that stakeholders are kept abreast of key quality and regulatory compliance objectives and goals. Work as an active member of the team by sharing the quality assurance and regulatory compliance knowledge and experience to resolve potential compliance issues and provide a positive and cohesive image when interacting with the client and internal customers.

Basic Qualifications:

-3 years of experience with working in an accredited laboratory

-Experience with accredited regulatory compliance

-Experience with Molecular Laboratory Methods

-Ability to obtain a security clearance

-BA or BS degree required

Additional Qualifications:

-Experience with laboratory project management in a laboratory environment

-Experience with lab-quality systems, including CLIA, CAP, ISO, GLP, or QSR

-Experience with writing SOPs and other laboratory documents

-Experience with basic laboratory techniques

-Experience with collecting and analyzing data

-Experience with Microsoft Office Suite, including Word, Excel, Access, and SharePoint

-BA or BS degree in Biological Science, Microbiology, Biotechnology, Biomolecular Engineering, Bioinformatics, or a related field preferred

Clearance:

 Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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