| Job Description: |
COMPANY
URL Pharma is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. We leveraged over 60 years of experience, as a generic pharmaceutical Ramp;D and manufacturing company, to successfully transition into a growing, profitable, and technology driven proprietary branded pharmaceutical business.
We are seeking talented professionals to be a part of our dynamic and diverse team of 500 employees. We currently have an opening for an Auditor in Quality Assurance Department.
AUDITOR ndash; QUALITY CONTROL
Assist with and contribute to the Quality Assurance external audit function and assure that all products from URL Pharma's vendors are in compliance with US cGMPs, and aligned with other industry regulations, expectations and lsquo;best practices'.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assist in the full implementation of Trackwise for audit program management, tasks include, but may not be limited to, writing governing SOP(s) and work instructions and populating the database with vendor amp; audit information. Track and update CAPA (may include both vendor and internal URL items) to closure. (highest priority)
Update Trackwise and any other auxiliary databases for audits, responses, CAPA, vendor certification
Assist in prioritizing amp; scheduling QA auditing assignments, including site audits and paper audits
Assist in the management of Vendor Certification Program
Update SOPs as necessary
Participate as a team member and/or perform unaccompanied site audits of API manufacturers, excipient manufacturers, contract testing laboratories, outsourced manufacturing sites, CROs, packaging component manufacturers, or other vendors providing critical goods or services to URL.
External Auditor position, all of the duties above, plus some Travel, up to 30-40%, may be required.
Perform other duties as assigned.
EDUCATION AND/OR EXPERTISE
Bachelor's degree (B.S.) in chemistry, other science, or engineering preferred. Knowledge of GCP and GLP regulations, experience with CROs or previous employment as CRA is a plus. Understands both the technical and clinical aspects of pharmaceutical products. Knowledge of critical issues; legal, technological and competitive which define the local and worldwide pharmaceutical marketplace. Has a general knowledge and understanding of business systems and general principles of manufacturing, laboratory operations, logistics, tech services, regulatory, registration, engineering, finance, marketing/sales, human resources, customer service and information systems.
BENEFITS
We offer a competitive compensation package that includes medical, dental and life insurance, Short term and long term disability insurance, 401K savings plan, paid time-off, tuition assistance and more!
URL/Mutual is an Equal Opportunity Employer M/F/V/D. Requirements See Job Description
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