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We are seeking QA / Quality Engineering professionals to support multiple quality, compliance, remediation, and capital project initiatives at a regulated pharmaceutical / medical device manufacturing site. Selected candidates may support QA oversight, protocol review and approval, CAPA, deviation investigations, remediation activities, clean-room/sterile manufacturing projects, equipment relocation, and regulatory compliance documentation.
Role Summary
Provide Quality Assurance / Quality Engineering support for quality, compliance, remediation, and project initiatives at a regulated pharmaceutical / medical device manufacturing site. Responsibilities may include QA oversight, protocol and documentation review and approval, signing documents on behalf of Quality Assurance, CAPA, deviation investigations, remediation activities, clean-room/sterile manufacturing support, equipment relocation, and regulatory compliance documentation.
Key Responsibilities
- Provide QA oversight for assigned quality, compliance, remediation, and project work.
- Review, approve, and sign protocols, reports, manufacturing documentation, change-control documentation, and project documentation on behalf of Quality Assurance.
- Respond to technical and compliance questions from project, engineering, manufacturing, and cross-functional teams.
- Support deviations, root-cause analysis, non-conformances, CAPA, and complaint handling in accordance with site procedures and applicable regulatory requirements.
- Support clean-room, sterile, aseptic, Grade C/D, environmental monitoring, bioburden, contamination-control, and cleaning-validation activities as applicable.
- Support equipment relocation, facility qualification, remediation activities, and quality-system documentation as applicable.
- Ensure remediation activities and quality documentation are completed in accordance with regulatory and internal requirements.
- Collaborate with cross-functional teams, including manufacturing, engineering, R&D, regulatory affairs, complaint handling, and supply chain, as applicable.
Requirements
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum 5 years of QA, Quality Engineering, or quality management experience in a regulated pharmaceutical or medical-device environment.
- Working knowledge of cGMP and applicable FDA requirements, including 21 CFR 210/211 and/or 21 CFR 820 as applicable.
- Experience with protocol review and approval, QA oversight, documentation review, deviations, root-cause analysis, CAPA, and quality-system documentation.
- Strong technical-writing, analytical, and problem-solving skills.
- Ability to work on-site in El Paso, Texas.
- Bilingual English/Spanish.
Preferred Qualifications
- Experience with sterile, aseptic, or combination drug-device manufacturing.
- Experience with Grade C/D clean-room operations, environmental monitoring, bioburden, contamination control, or cleaning validation.
- Knowledge of ISO 13485 and ISO 14971.
- Experience with CAPA, remediation, non-conformance management, regulatory findings, complaints, or field issues.
- Experience with TrackWise or similar electronic CAPA / quality systems.
- Experience with DHF, Risk Management Files, test method validation, sampling plans, SPC, FMEA, or quality-engineering tools.
- CQA or CQE certification.
- Experience in FDA remediation, Warning Letter, or Consent Decree environments.
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