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TOLMAR Inc. QA Specialist II - Supplier Quality/Audits in Fort Collins, Colorado

Purpose and ScopeThe Quality Assurance Specialist II is primarily responsible for supportingand managing supplier quality-related processes and site inspection readinessactivities.Essential Duties and ResponsibilitiesSupport and manage audit and inspection readiness activities, includingproviding training on associated processes/concepts to all levels ofemployees.Support post-audit and inspection activities (e.g. coordinating meetings,compiling data, etc.).Manage the Supplier Change Notification Program, including completion ofimpact assessments.Own supplier-related quality events (deviations), including completingthe investigation of the event and collaborating with technical subject matterexperts and suppliers.Support the supplier complaint process as assigned.Support quality agreement program, including initiating and coordinatingquality agreement drafts.Support supplier audit program, including performing the audit, auditreport review, supplier follow up, etc.Support the supplier qualification and re-evaluation programs, includingperforming historical quality reviews, risk assessment and completingsummary evaluations.Support and perform supplier impact assessments as assigned.Support and own initiation of new procedures and revisions to currentdepartment procedures.Perform other duties as assigned.Knowledge, Skills and AbilitiesWorking knowledge of cGMP guidelines and as well as international regulations(e.g. 21 CFR 210/211, 21 CFR 11, ISO 13485, Eudralex Volume 4 PartII, ISO 9001, etc.).Knowledge of QA concepts related to raw material and supplier managementactivities.Knowledge of QA concepts related to inspection readiness activities.Knowledge of change control process, including ownership of change controls.Knowledge of deviation/investigation process, including investigator skills.Ability to clearly communicate (verbally and in writing) and work wellwith employees at all levels.Ability to effectively collaborate with technical subject matter experts andsuppliers.Ability to train colleagues on new processes and concepts.Procedure and report writing capability (strong technical writing skills)Computer literacy in Microsoft Word, Access, Excel, and others as required.Independent, organized, and able to schedule work without supervision tomeet schedule deadlines.Core ValuesThe QA Specialist II - Supplier Quality/Audits is expected to operatewithin the framework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task. Education and ExperienceBachelor's degree in scientific discipline required.Five or more years of experience in the pharmaceutical or medical deviceindustry in Quality Assurance required.Supplier and raw material management program experience preferred.Audit experience, including supplier audits and site regulatory inspectionspreferred.Inspection readiness experience preferred. Working ConditionsMonday through Friday, 8:00 a.m. - 5:00 p.m., with availability towork evenings and weekends as necessary.Domestic travel may be required, with occasional international travel, upto 25% of the time.Compensation and BenefitsAnnual pay range: $85,000 + Depending on ExperienceLink to general benefits information: