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.