Sr. Scientist - Process Compliance

Upsher-Smith   •  

Denver, CO

5 - 7 years

Posted 270 days ago

This job is no longer available.

The Sr. Scientist – Process Compliance is a technical role that will investigate and facilitate the written site Exception (deviation) Reporting Program. This includes partnering with a cross functional team to drive investigations related to manufacturing, packaging, facilities, utilities and equipment to determine root cause, impact, and corrective/preventative actions (CAPA). Candidate will effectively utilize quality and risk management processes/tools and have strong technical writing skills.

Responsibilities:

  • Investigate and author reports related to manufacturing and packaging deviations within established timelines.
  • Use process knowledge and root cause determination techniques to troubleshoot and identify root cause, failure analysis, and determination of appropriate corrective/preventative actions.
  • Design and conduct scientific studies to investigate exception occurrences and atypical observations. Makes determinations of product impact as it relates to deviations.
  • Ensure CAPAs are implemented through cGMP/Quality Systems (e.g SOP updates, batch record revisions, training).
  • Collaborate with primary support groups such as engineering, operations, IQM and Maintenance.
  • Responsible for technical writing to ensure clear, concise investigation summaries.
  • Establish and track appropriate metrics and provides data to Leadership on a regular basis. 
  • Maintains current understanding of quality systems, optimal product/process design methodology, product/material capability and regulatory requirements. Lead frequent meetings with Exception Report stakeholders to collaborate on tasks for ER closure.
  • Provide input and drives closure on SOP’s, batch records, forms and other cGMP related documents needing to be developed or revised to support CAPA. Provide consultation and support to both Technical Services and other functional areas as required.
  • Supportinternal, 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 minimum of 6+ years of experience in pharmaceutical development/formulation, pharmaceutical cGMP manufacturing/packaging equipment, or pharmaceutical process validation and/or equipment, systems, utilities Qualification (manufacturing and packaging equipment). Must have 4+ years of experience in solid oral dosage pharmaceuticals. Strong written and verbal communication skills required, including technical writing. Experience in investigating deviations in a cGMP strongly preferred.Experience working in a compliance/quality support role preferred.

Upsher-Smith Laboratories, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Job ID 6971