What are the responsibilities and job description for the QA Compliance Auditor position at ImprimisRx® - A Harrow Company?
Job Summary
The QA Compliance Auditor is responsible for cGMP compliance audits of the company’s suppliers/vendors, contract organizations, and internal Harrow Health sites. As a QA Compliance Auditor, you will have the opportunity in a high-visibility role to ensure that Harrow’s suppliers/vendors, contractor organizations, and the company’s sites continue to enable our mission by providing high-quality, safe, and effective products. This role supports the various businesses within Harrow Health, including our 503A, 503B, and approved drug product businesses.
Core Responsibilities
• Conduct onsite, remote, and/or paper-based Qualification audits of the company’s raw material suppliers/vendors and contract organizations • Prepare and issue audit reports and/or non-compliances to respective suppliers; collaborate with them for prompt response and resolution of identified issues • Propose recommended qualification of suppliers/vendors, endorse and contract organizations • Help maintain the Supplier Qualification program and associated documentation • Oversee and negotiate Quality Agreements between suppliers and Harrow • Collect, trend, and report supplier quality metrics • Review change control for supplier/vendor qualification status • Conduct onsite internal cGMP audits of Harrow’s sites and support regulatory inspections • Prepare and issue audit reports to communicate risks/non-compliances to respective department heads and Quality Leadership; collaborate with the site to ensure for prompt implementation of corrective and preventive actions (CAPAs) of identified issues • Other duties as assigned by leadership
Qualifications & Requirements
• Expert knowledge of US FDA pharmaceutical and/or drug compounding cGMP regulations • Bachelor’s degree in life sciences, engineering, or equivalent work and education in a related field • 3 years of experience in pharmaceutical supplier quality preferred • Experience conducting cGMP audits; auditor certification preferred • Willingness to travel (up to 50% of the time) • Experience working autonomously with proven ability to meet deadlines • Experience with full life cycle project management (initiation, planning, design, and execution) • Strong organizational skills with the proven ability to prioritize, multitask, and be detail-oriented • Strong communication skills, both verbal and written • Strong collaboration and teamwork skills: good communications, facilitation, and coordination • Ability to communicate effectively with individuals at various levels of the organization, various partners, and various departments or disciplines • Strong written, verbal, and presentation communication skills. • Ability to think creatively in confronting issues and pursuing novel approaches to old problems. • Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards. • Ability to manage multiple projects simultaneously, adjusting priorities as needed and meeting deadlines.
Position Type
• on-site
Travel
• Up to 50% to audit suppliers.
The QA Compliance Auditor is responsible for cGMP compliance audits of the company’s suppliers/vendors, contract organizations, and internal Harrow Health sites. As a QA Compliance Auditor, you will have the opportunity in a high-visibility role to ensure that Harrow’s suppliers/vendors, contractor organizations, and the company’s sites continue to enable our mission by providing high-quality, safe, and effective products. This role supports the various businesses within Harrow Health, including our 503A, 503B, and approved drug product businesses.
Core Responsibilities
• Conduct onsite, remote, and/or paper-based Qualification audits of the company’s raw material suppliers/vendors and contract organizations • Prepare and issue audit reports and/or non-compliances to respective suppliers; collaborate with them for prompt response and resolution of identified issues • Propose recommended qualification of suppliers/vendors, endorse and contract organizations • Help maintain the Supplier Qualification program and associated documentation • Oversee and negotiate Quality Agreements between suppliers and Harrow • Collect, trend, and report supplier quality metrics • Review change control for supplier/vendor qualification status • Conduct onsite internal cGMP audits of Harrow’s sites and support regulatory inspections • Prepare and issue audit reports to communicate risks/non-compliances to respective department heads and Quality Leadership; collaborate with the site to ensure for prompt implementation of corrective and preventive actions (CAPAs) of identified issues • Other duties as assigned by leadership
Qualifications & Requirements
• Expert knowledge of US FDA pharmaceutical and/or drug compounding cGMP regulations • Bachelor’s degree in life sciences, engineering, or equivalent work and education in a related field • 3 years of experience in pharmaceutical supplier quality preferred • Experience conducting cGMP audits; auditor certification preferred • Willingness to travel (up to 50% of the time) • Experience working autonomously with proven ability to meet deadlines • Experience with full life cycle project management (initiation, planning, design, and execution) • Strong organizational skills with the proven ability to prioritize, multitask, and be detail-oriented • Strong communication skills, both verbal and written • Strong collaboration and teamwork skills: good communications, facilitation, and coordination • Ability to communicate effectively with individuals at various levels of the organization, various partners, and various departments or disciplines • Strong written, verbal, and presentation communication skills. • Ability to think creatively in confronting issues and pursuing novel approaches to old problems. • Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards. • Ability to manage multiple projects simultaneously, adjusting priorities as needed and meeting deadlines.
Position Type
• on-site
Travel
• Up to 50% to audit suppliers.