Job Description

Quality Assurance Specialist Job Description

• Maintain a safe, fast-paced, and positive laboratory environment.
• Interact directly with clients on an as-needed basis.
• Assist in training of other personnel as requested.
• Ensure safety and compliance with governmental regulations.
• Interact with FDA and clients as needed in the event of an inspection/audit.
• Follow all applicable Good Clinical Practice Regulations.
• Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards.
• For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study.
• Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection.
• Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately.
• Maintain a copy of a master schedule of all studies, include all pertinent information.
• Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
• Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
• Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB (if applicable). All Adverse and Serious Adverse Events are ensured to be included in the study folder and archived upon study completion.
• Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
• Prepare and sign a statement to be included with the final study report which specifies the date(s) inspections were made and findings reported to Management and to the Principal Investigator.
• Put in writing and maintain the responsibilities, procedures and records applicable to the Quality Assurance Department, and the method of indexing such records.
• Maintain and regularly update resume and training records.
• Other duties as needed.

Qualifications

Education and Experience:

- Associate’s degree or equivalent, and one year relevant work experience.

- At the discretion of Management, additional education may qualify an individual with less experience

Primary Duties and Responsibilities:

1. Support the QA department and management to maintain ECRL Quality Management System.
2. Conduct audits to verify compliance with protocols, SOPs, GCP and GLP during study conduct and communicate non-conformances to the principal investigator and management.
3. Timely and accurately review study stats, reports, master files, CRFs , AE forms and any other supportive documents for concurrence with the protocol and compliance with GCP and Eurofins CRL SOPs.
4. Provide support, guidance and training to study staff regarding proper understanding and execution of applicable GCP guidelines and SOPs.
5. Collaborate with staff to ensure corrective actions are accomplished.
6. Participate in sponsor and agency audits
7. Maintain ECRL KPIs, SOPs, and staff training records
8. Collaborate with all other quality activities as assigned by QA management.

Additional Information

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.