Upsher-Smith Laboratories, Inc. Sr. Scientist - Process Compliance in Denver, Colorado

The Sr. Scientist - Process Compliance is a technical role that willinvestigate and facilitate the written site Exception (deviation)Reporting Program. This includes partnering with a cross functional team todrive investigations related to manufacturing, packaging, facilities,utilities and equipment to determine root cause, impact, andcorrective/preventative actions (CAPA). Candidate will effectivelyutilize quality and risk management processes/tools and have strongtechnical wResponsibilities:Investigate and author reports related to manufacturing and packagingdeviations within established timelines.Use process knowledge and root cause determination techniques to troubleshootand identify root cause, failure analysis, and determination ofappropriate corrective/preventative actions.Design and conduct scientific studies to investigate exception occurrences andatypical observations. Makes determinations of product impact as it relates todeviations.Ensure CAPAs are implemented through cGMP/Quality Systems (e.g SOPupdates, batch record revisions, training).Collaborate with primary support groups such as engineering, operations,IQM and Maintenance.Responsible for technical writing to ensure clear, concise investigationsummaries.Establish and track appropriate metrics and provides data to Leadership on aregular basis.Maintains current understanding of quality systems, optimalproduct/process design methodology, product/material capability andregulatory requirements. Lead frequent meetings with Exception Reportstakeholders to collaborate on tasks for ER closure.Provide input and drives closure on SOP's, batch records, forms andother cGMP related documents needing to be developed or revised to supportCAPA. Provide consultation and support to both Technical Services and otherfunctional areas as required.Support internal, external and regulatory inspections including FDA,EMEA, and third party audits related to the Exception Reporting Program.Write and enhance applicable department SOP's and guidelines.Requirements:Bachelor's degree in an engineering or scientific discipline and a minimumof 6+ years of experience in pharmaceutical development/formulation,pharmaceutical cGMP manufacturing/packaging equipment, or pharmaceuticalprocess validation and/or equipment, systems, utilities Qualification(manufacturing and packaging equipment). Must have 4+ years ofexperience in solid oral dosage pharmaceuticals. Strong written and verbalcommunication skills required, including technical writing. Experience ininvestigating deviations in a cGMP strongly preferred.Experience working in acompliance/quality support role preferred.Upsher-Smith Laboratories, LLC is committed to providing equal employmentopportunity to all applicants and employees according to all applicable equalopportunity and affirmative action laws, directives and regulations offederal, state and local governing bodies and agencies. In keeping with thiscommitment, Upsher-Smith Laboratories, LLC will recruit, hire, trainand promote persons in all job titles, without regard to race, color,creed, religion, sex (including factors related to pregnancy or childbirth), national origin, age, marital status, familial status,disability, sexual orientation, gender identity status with regard topublic assistance, employment status, local human rights commissionactivity, status as a protected veteran, genetic information, atypicalhereditary cellular or blood trait, or any other protected category.Upsher-Smith Laboratories, Inc. is committed to providing equal employmentopportunity to all applicants and employees according to all applicable equalopportunity and affirmative action laws, directives and regulations offederal, state and local governing bodies and agencies. In keeping with thiscommitment, Upsher-Smith Laboratories, Inc. will recruit, hire, trainand promote persons in all job titles, without regard to race, color,creed, religion, sex (including factors related to pregnancy or childbirth), n