• Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and any other related Regulations which may apply to company activities.
• Under guidance of QA Management, conducts audits of computer system validation (CSV) and analytical instrument qualification (AIQ) files for accuracy and completeness. Verifies that the final summary reports accurately reflect the data generated. Audits regulated testing for conformance to the Validation Master Plan (VMP) SOPs, CSV or AIQ Plan and applicable GLP regulations.
• Under guidance of QA Management, conducts audits and/or reviews, as applicable, of protocols, plans, raw data, final report and associated files, for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated. Conducts critical phase, in-lab inspections of any regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, applicable documents and relevant GLP regulations.
• Under guidance of QA Management, prepares written records of all inspections and submits inspection reports to the study director and management, indicating deviations from or conformance with GLPs, protocols, and SOPs.
• Reports periodically to supervisor regarding status of inspection/audit activities.
• Assists in reviewing, writing, and maintaining up-to-date SOPs for QA unit and assists in the preparation of standard operating procedures related to CVS and AIQ audits.
• Works closely with operational CSV/AIQ leads, at the site and divisional level
• Trains and/or peer-reviews QA auditors and/or designated staff, as assigned by QA Management
• Works closely with QA personnel in overall QA functions.
• Updates the master schedule, as necessary.
• Promotes company’s safety policies, practices, and procedures in order to maintain a safe work environment.
• Other duties as assigned.

• Bachelor’s degree in chemistry, engineering, or related field, preferred
• At least 5 years of auditing experience in a regulated GLP/GCP environment
• At least 4 years of direct auditing experience in Computer Systems Validation (CSV) and Analytical Instrument Qualification (AIQ) within a GLP/GCP regulated research environment
• Any similar, equivalent combination of education and experience

• Proficient in Oral & Written communication skills
• Must able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
• Travel is required <10% , Domestic/International, Daily/Overnight

• Must be able to work in an office environment
• Must be able to work in laboratory setting with exposure to biohazards
• Must be able to wear appropriate personal protective equipment (PPE)
• Must be able to work in environments with variable noise levels
• Must have the ability to stand /sit/walk for extended periods of time
• Must have the ability to lift/push/pull 10 lbs occasionally
• Must have the ability to identify and distinguish colors
• Must have the ability to work in indoors/outdoors at variable temperatures

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability