Quality Assurance Specialist

Eurofins•Austin, TX

1d•Onsite

About The Position

This is a quality assurance position that requires familiarity with microbiology theories and practices. Approximately 80% of time is spent reviewing laboratory documentation including laboratory raw data, datasheets and reports prepared for customers. Approximately 20% of time is spent actively supporting the Quality Management System, including observation of the facility and laboratory operations to investigate potential gaps in compliance.

Requirements

B.S. in a biological science (PROOF OF GRADUATION REQUIRED IF HIRED).
Good technical knowledge of microbiology theory and practice.
Strong detail orientation.
Ability to be a self-starter and work both autonomously and cooperatively with others in a small-company environment.
Strong interpersonal skills.
A positive outlook with a strong desire to continue to learn more and gain more experience.
Prior experience in the quality assurance space.
Knowledge of and experience with Good Clinical Practice (GCP) regulations.
Proficiency in MS Office, especially Excel.
Understanding of statistics
Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsibilities

Maintain a safe, fast-paced, and positive laboratory environment.
Once proficient and having undergone a certain level of training, assist in training of other personnel as requested.
Ensure safety and compliance with governmental regulations and industry standards.
Interact with FDA, other regulatory agencies and clients as needed in the event of an inspection/audit.
Support and participate in all activities related to the Quality Management System and to maintain ECRL ISO certification.
Follow all applicable Good Clinical Practice Regulations and Good Laboratory Practices in the QA role.
Generally, monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice and Good Laboratory 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, in collaboration with the labs, a master schedule of all studies, including all pertinent information to meet clients’ deadlines.
Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
Review all study forms and supportive documentation for concurrence with the protocol and compliance with GCP and ECRL SOPs
Review draft and final study report, along with any necessary deliverables, to assure that such report or deliverables accurately describe 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 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 updated resume and training records.
Other QA duties as needed.