Quality Assurance/Control Specialist - Laboratory setting

Job DescriptionJob Description

This location is a Contract Quality Control Chemistry and Microbiology Laboratory. This position is quality assurance/control oversight driven with focus in out of specifications and internal audits. The average work split is 10% of the time spent in the laboratory doing quality assurance/control inspections (e.g., procedural/test in-phase inspections and facility inspections) and approximately 90% of the time is spent doing quality assurance desk work (e.g., final report audits and facility record audits).

The position will be located in the Dallas Area reporting to Team Lead in the Austin area.

Required Qualifications:

• Bachelor’s degree

• Excellent writing and analytical review skills for reporting and testing.

• Supreme attention to detail.

• Problem-solving skills including the ability to understand root cause analysis.

• Ability to provide excellent, consistent service to both internal and external customers.

• Maintain a positive, collaborative attitude.

• Ability to be a self-starter and critical thinker while working cooperatively with others in a small-company environment.

Desired Qualifications:

• Bachelor’s Degree with a Chemistry focus.

• 1+ years of prior experience as QA/QC for a GMP testing lab.

• Prior work experience in a laboratory setting.

• Deep technical knowledge of microbiology theory and practice.

• Experience in the safe handling of pathogenic microorganisms.

• Experience with safety audits.

• Proficiency in Microsoft Office

• Experience with root cause analysis tools

• Ability to travel as needed to HQ for training/events.

Job Duties:

• Monitor GMP or ISO-compliant studies, as needed, to assure management that the facilities, equipment, personnel, methods, practices, records, and controls conform to the regulations.

• Determine that no deviations from written methods or standard operating procedures were made without proper authorization and documentation.

• Review the final study report to ensure that such report accurately describes the methods and standard operating procedures and that the reported results accurately reflect the raw data details of the study.

• Assist in conducting quarterly facility inspections and report findings to Quality Team Lead.

• Assist in writing or reviewing Standard Operating Procedures (SOPs).

• Understand the CAPA process and be familiar with and able to perform root cause analysis as needed.

• Maintain and improve lab documents and record-keeping procedures.

• Assist in reviewing protocols, experimental datasheets, and reports.

• Assist with basic laboratory needs, such as cleaning, organization, or equipment validation.

• Interact with and provide detailed information to collaborating personnel.

• Maintain a safe, fast-paced, and positive laboratory environment.

• Other duties, as assigned.