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

Legalpmpartners

El Paso (TX)

On-site

USD 55,000 - 83,000

Full time

5 days ago
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Job summary

Legalpmpartners in El Paso, TX is seeking a Quality Assurance Specialist (Contractor, 1099) to support QA operations in a pharmaceutical manufacturing setting. The role collaborates with Manufacturing, Validation, Engineering, and Quality teams to drive investigations, documentation, and continuous improvement.

The candidate will review GMP documentation, batch records, and reports, support deviations, CAPAs, change controls, audits, and ensure regulatory compliance.

Qualifications

  • Bachelor’s degree in a related scientific/technical field is required.
  • 3+ years of quality assurance in regulated manufacturing environments preferred.
  • Experience with GMP, deviations, CAPA, Change Control, and audits.

Responsibilities

  • Support daily QA activities in pharmaceutical manufacturing.
  • Review and approve GMP documents, batch records, procedures, 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 regulatory requirements.
  • Provide QA support to cross-functional teams and maintain records.
  • Assist with training, SOP implementation, and quality system activities.

Skills

Attention to detail
Documentation
Cross-functional collaboration
Communication

Education

Bachelor’s degree in Pharmaceutical Sciences
Chemistry
Biology
Engineering

Tools

Microsoft Office
Electronic quality systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Contractor - 1099 Professional El Paso, TX, US

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.

Supportdeviations, investigations, CAPAs, change controls, and non-conformances.

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

Ensure compliance withFDA, cGMP, and applicable regulatory requirements.

Provide QA support toManufacturing, Validation, Engineering, and other cross-functional teams.

Review quality and validation documentation for compliance and completeness.

Supporttraining, 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 withdeviations, 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 withMicrosoft Office and electronic quality systems.

Ability to workon-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 supportingFDA-regulated environmentsis preferred.

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