QA Compliance Auditor

Harrow, Inc.•Ledgewood, NJ

1d•Onsite

About The Position

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 compounding, 503B compounding, and approved drug product businesses.

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.

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