TOLMAR Inc. QA Auditor in Fort Collins, Colorado
Purpose and ScopePerform quality system audits, both internal and external to the company.Essential Duties & Responsibilities Assist in managing the supplier audit and approval program, includingsetting audit dates with suppliers, and performing audits withindepartmental budgetary guidelines. Maintain the supplier audit schedule per internal procedure and businessrequirements. Document audit findings, prepare audit reports detailing deficienciesfound during audits and provide follow-up assessments to CAPA actions taken bysuppliers to correct audit deficiencies. Assist in managing Supplier Notifications for materials, components,supplier packaging changes, supplier name changes, etc. per internalprocedure. Assist with internal audits, including report writing and issuance andtracking of findings for closure. Work with development teams to identify new suppliers for materials andcomponents. Provide QA review for new part number requests in the electronicdocumentation system for raw materials and components. Interact with suppliers of raw materials and components for qualityrelated issues through the issues and exceptions electronic system. Provide supplier information during foreign and domestic regulatory agencyinspections and marketing partner audits. Other duties as required.Requirements Knowledge, Skills & Abilities Working knowledge of drug or device cGMPs, knowledge of API,excipient, and/or component manufacturing processes as well as qualitycontrol laboratories. Knowledge of QA principles, concepts, systems, industry practices,and standards. Ability to read and understand procedures. Ability to perform system audits to determine compliance to requirements. Skill in computer operations in Microsoft Word, Access, Excel, andothers if required. Ability to work independently and in teams. Ability to clearly communicate (oral & written) and work well withemployees at all levels. Bilingual communication skills are beneficial but not required.Education & Experience Bachelor s degree in Chemistry or other scientific discipline required. Three or more years of experience in the pharmaceutical or medical deviceindustry in a Quality Assurance capacity required. Three or more years of audit experience required.Working Conditions Working conditions are normal for an office environment. Some overtime andweekend work may be necessary. Domestic travel is required, with occasional international travel, upto 25% of the time.