cGMP Quality Assurance Specialist I

mycts; San Marcos (TX); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

mycts seeks a Quality Specialist to ensure cGMP compliant lab testing processes and accurate final release of results to customers. Under supervision, you will apply standard procedures and contribute to performance improvement and data integrity.

You will review QC data, approve test results, maintain records, and support cross-department collaboration, training, and audits while upholding confidentiality and SOP adherence in a regulated lab environment.

Formación

• Bachelor's degree required.
• 2+ years in a cGMP regulated environment for Level II.
• 4+ years in a cGMP regulated environment for Level III, with training experience.

Responsabilidades

• Reviews and approves QC verifications for routine testing of biological samples.
• Approves final test results for release to laboratory customers.
• Maintains records and ensures confidentiality and SOP compliance.
• Supports archival record organization and SOP adherence.
• Partners with departments; resolves issues by following SOPs and escalation.
• Analyzes environmental monitoring and addresses temperature/humidity issues.
• May review equipment re-qualifications and instrument release.
• May review calibrations and verifications to meet acceptance criteria.
• May review critical reagents and assist with lot changes.
• May pack and ship supplies and samples when required.
• Participates in performance improvement teams and training.
• Ensures quality customer service and regulatory compliance.

Conocimientos

Quality control

Documentation

Teamwork

Problem solving

Confidentiality

Computer skills

Windows proficiency

Communication

Educación

Bachelor's degree

cGMP regulation knowledge

Descripción del empleo

mycts seeks a Quality Specialist to ensure cGMP compliant lab testing processes and accurate final release of results to customers. Under supervision, you will apply standard procedures and contribute to performance improvement and data integrity.

You will review QC data, approve test results, maintain records, and support cross-department collaboration, training, and audits while upholding confidentiality and SOP adherence in a regulated lab environment.