QA Specialist | Pharmaceutical | El Paso, TX | On Site

Job Description

Job Description

Location: El Paso, TX

Position Summary

The Quality Assurance Specialist will support quality operations within a pharmaceutical manufacturing environment, ensuring compliance with FDA, cGMP, and company quality standards. This role will collaborate with Manufacturing, Validation, Engineering, and Quality teams to support quality systems, investigations, documentation, and continuous improvement initiatives.

Main Responsibilities

• Support daily Quality Assurance activities within pharmaceutical manufacturing operations.

• Review and approve GMP documentation, batch records, procedures, protocols, and reports.

• Support deviations, investigations, CAPAs, change controls, and non-conformances.

• Participate in GMP audits, inspections, and quality improvement initiatives.

• Ensure compliance with FDA, cGMP, and applicable regulatory requirements.

• Provide QA support to Manufacturing, Validation, Engineering, and other cross-functional teams.

• Review quality and validation documentation for compliance and completeness.

• Support training, SOP implementation, and quality system activities.

• Identify compliance gaps and assist with corrective and preventive actions.

• Maintain accurate and timely quality records and documentation.

General Requirements

• Experience working in a pharmaceutical manufacturing environment.

• Strong knowledge of FDA regulations and cGMP requirements.

• Experience with deviations, CAPA, Change Control, and investigations.

• Experience reviewing GMP and quality documentation.

• Strong attention to detail and documentation skills.

• Ability to work effectively with cross-functional teams.

• Strong written and verbal communication skills.

• Proficiency with Microsoft Office and electronic quality systems.

• Ability to work on-site, full-time in El Paso, Texas.

Education and Experience Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific/technical field.

• 3+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or regulated manufacturing industry.

• Experience in GMP-regulated manufacturing operations.

• Experience with quality systems such as Deviation, CAPA, Change Control, SOPs, and Audits.

• Experience supporting FDA-regulated environments is preferred.

• Bilingual English/Spanish is a plus.