Quality Assurance Auditor I

Piper Clinical Solutions is currently seeking a Quality Assurance Auditor I in the area of Gaithersburg, MD. The Quality Assurance Auditor I will be working within the General Toxicology Division in order to support a well-established biotechnology company that provides services focused on in-vivo models of human diseases.

Responsibilities for the Quality Assurance Auditor I:

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  Perform protocol, critical phase, raw data, and report audits for compliance with Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), and protocol and report finding to appropriate personnel
• Review in-life phases and facilities as required for compliance with GLPs and SOPs
• Ensure adherence to health and safety procedures, SOPs, and GLP standards by observing technical and professional staff
• Ability to use Master Schedule program as required to input and update information
• Ability to learn electronic database collection system that is used in data generation (ex: proper use, reporting, audit trails, security/Part 11 compliance, data correction, QC, etc)
• Participate in internal facility inspections, quality assurance inspections, and the validation of equipment and software
• Ability to adhere to laboratory health and safety procedures, Standard Operating Procedures (SOPs), company policies and guidelines, and federal and/or local regulations, as applicable

Qualifications for the Quality Assurance Auditor I:

• Strong written and verbal communication skills
• Time management skills
• 2 (two) years of experience with GLP auditing
• Bachelor of Science/Art in Biological Science or related field

Compensation for the Quality Assurance Auditor I:

• 
  Salary range: $65,000 - $75,000 (commensurate with relevant experience)
• Benefits include: Health, Dental & Vision Insurance, 401k

Keywords:

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