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Quality Assurance Specialist

1 month ago

Richardson, Texas, United States Microchem Laboratory Full time
Job Overview

This is a quality assurance/control position in a Microbiology Contract Laboratory, defined by 21 CFR Part 211 and Part 111, and other regulatory items as appropriate. The role involves a 20% laboratory quality assurance/control inspection and 80% quality assurance desk work split.

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

Key Responsibilities:


Bachelor's degree


Excellent writing and analytical review skills for reporting and testing.


Supreme attention to detail.


Problem-solving skills, including 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.

Preferred Qualifications:


Bachelor's Degree with a biological science 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.


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


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


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.