Quality Assurance Specialist
4 weeks ago
This is a quality assurance position in a Microchem Laboratory and is defined in regulatory guidelines. The role involves ensuring that facilities, equipment, personnel, methods, practices, records, and controls conform with regulations.
The position will be located in the Dallas Area and will report to a Team Lead in the Austin area.
Required Qualifications:
Bachelor's degree in a biological science or related field.
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 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.
Job Duties:
Monitor GMP or ISO-compliant studies to ensure compliance with 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 accuracy and compliance.
Assist in conducting quarterly facility inspections and report findings.
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.
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