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MANAGER-R&D - Quality Assurance
San Antonio, TX
May 17, 2025
Full-time
Full Job Description
Who We Are:

The Quality Assurance group within the Chemistry and Chemical Engineering Division ensures conformance and compliance to regulatory requirements and quality systems. We support a diverse range of quality programs covering analytical and chemistry testing including nuclear chemistry, pharmaceutical development and medical devices.

Objectives of this Role:
  • Oversee a group of Quality Scientists and Technicians.
  • Perform, review and approve audits and surveillances that are performed to determine and evaluate the level of compliance/conformance throughout the Chemistry and Chemical Engineering Division.
  • Responsible for maintaining ongoing accreditation and certification to ISO 9001, ISO/IEC 17025, ISO/IEC 17020 and ISO 13485, ISO 14001.
  • Provide quality assurance support to Good Manufacturing Practice, Good Laboratory Practice and Medical Device programs.
  • Oversee QA support to work performed under 10CFR50 Appendix B/NQA-1.
  • Release investigational and new drugs manufactured under GMP for development and clinical trial use.
  • Develop and maintain Division operation and test procedures related to quality, safety and the environment.
  • Interface with employees, division management and customers as necessary on quality related items.
  • Formulate and improve policies and procedures related to quality, safety and environmental issues.
Daily and Monthly Responsibilities:
  • Manage a quality assurance team.
  • Host, support and respond to quality audits and assessments by external groups and/or clients. This includes audits by federal and state regulators.
  • Provide QA support, oversight and compliance assistance for ongoing projects in areas that include analytical testing, good laboratory practice, medical devices, and pharmaceutical development.
  • Verify compliance to quality, safety, environmental and program plans to ensure contractual requirements are met. Provide training to the Chemistry and Chemical Engineering Division.
  • Develop and maintain documentation related to the quality, safety, and environmental systems within the Division. This includes maintenance of the archive for the Division.
  • Assist with document and record control to ensure regulatory compliance.
  • Monitor compliance with the quality management system, approve corrective action plans, perform and approve internal audits.
Requirements:
  • Requires a Bachelors degree in Chemistry, Biology or Chemical Engineering.
  • 10 years: Working in fields such as Pharmaceutical cGMP, Quality systems ISO 9001, ISO13485, quality control for data from laboratories.
  • 5 years: Demonstrated leadership and managements skills with direct supervision of technical teams.
  • 3 years: Quality Assurance, Quality Control, Regulatory Compliance and Affairs and Auditory experience.
  • A valid/clear driver's license is required.
PDN-9eef8fe1-4d28-4516-98f2-fc64c5f274bb
Job Information
Job Category:
Other
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MANAGER-R&D - Quality Assurance
Southwest Research Institute
San Antonio, TX
May 17, 2025
Full-time
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