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Quality Specialist I - QA Compliance

Company: Tolmar
Location: Fort Collins
Posted on: June 24, 2022

Job Description:

Purpose and ScopeThe Quality Specialist I - QA Compliance is primarily responsible for supporting supplier quality and internal audit related processes and site inspection readiness activities.Essential Duties & ResponsibilitiesSupport audit and inspection readiness activities, including providing training on associated processes/concepts to all levels of employees.Support post-audit and inspection activities (e.g. coordinating meetings, compiling data, etc.).Support the Supplier Change Notification Program, including completion of impact assessments.Support supplier-related quality events (deviations), including completing investigations and collaborating with technical subject matter experts and suppliers.Support the supplier complaint process as assigned.Support quality agreement program, including initiating and coordinating quality agreement drafts.Support supplier audit program and internal audit program as assigned.Support supplier qualification and re-evaluation programs, including performing historical quality reviews, risk assessment and completing summary evaluations.Submit and monitor revisions to current department procedures.Provide supplier quality information to APQR team for annual reports.Support site inspection readiness activities as assigned.Perform other duties as assigned.Knowledge, Skills & AbilitiesWorking knowledge of GMP/cGMP guidelines.Knowledge of QA concepts related to raw material and supplier management activities.Knowledge of QA concepts related to inspection readiness activities.Knowledge of change control process.Knowledge of deviation/investigation process, including investigator skills.Ability to clearly communicate (verbally & in writing) and work well with suppliers and employees at all levels.Ability to effectively collaborate with technical subject matter experts and suppliers.Procedure and report writing capability.Computer literacy in Microsoft Word, Excel, PowerPoint and others as required.Independent, organized, and able to schedule work with minimal supervision to meet schedule deadlines.Core ValuesThe Quality Specialist I is expected to operate within 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 of our 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 & ExperienceBachelor's degree in scientific discipline preferred; equivalent education and experience of two or more years of related experience with an Associate's degree in a scientific discipline, or four or more years of related experience with no degree.One or more years of experience in the pharmaceutical or medical device industry required; two or more years of experience in Quality Assurance preferred.Supplier and raw material program management experience preferred.Audit experience, including supplier or internal audits and site regulatory inspections preferred.Inspection readiness experience preferred.Compensation and BenefitsPay range: $65,000 - $75,000 depending on experienceBenefits summary: compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.Working ConditionsWorking conditions are normal for an office environment. Some overtime may be necessary.Local travel may be required.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Tolmar, Fort Collins , Quality Specialist I - QA Compliance, Other , Fort Collins, Colorado

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