Compliance Scientist I - MST (Hybrid - Colorado - 32 Work Week)

Tolmar Careers • Fort Collins, CO

13h • $90,000 - $95,000 • Hybrid

About The Position

Purpose and Scope Independently develops, tests, validates and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency. Mentors less experienced analysts. The Compliance Scientist I uses in-house standard operating procedures, compendial documents, industry guidances and pharmaceutical industry knowledge to perform tasks. Fosters an environment of safety and company culture. Essential Duties & Responsibilities: Analytical Services Apply and stay current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently. Advise on project decisions with potential regulatory consequences. Knowledgeable in the execution of compendial methods, specifically USP and EP. Complete impact assessments for compendial updates and assist QA Development in initiation of related change controls. Assist the Quality Control (QC) laboratory in troubleshooting test method issues. Efficiently write, review, and approve technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies. Adhere to validated test methods, standard operating procedures, and applicable guidance. Use technical discretion in designing, executing, and interpreting experiments that contribute to project strategies. Serve as contact for vendors and contract laboratories. Present supplier notifications and impact assessments to MST Change Control meetings. Complete assessments and resulting change actions for supplier items. Interact closely with project teams across departments and outside testing laboratories. Interpret, review, and discuss data from outside testing laboratories. Provide analytical support to Formulation Development and interact with team members in exchanging technical expertise. Act as a subject matter expert (SME) in instrumentation, methodology, and guidance. Perform other duties as assigned. Audits and Inspections Lead communications and strategy for external and internal audits, serving as primary contact for regulatory inspectors and auditors. Develop and implement compliance programs, proactively identifying and mitigating risks. Lead resolution of complex compliance issues, collaborating with regulatory agencies and internal stakeholders. Escalate and manage significant risks, ensuring timely and effective corrective actions Support self-audit efforts and developed strategies for compliance and remediation. Act as Training Admin-Assign and verify training for new employees and expedited documents. Data Analytics and Trending Support the design and execution of Continued Process Verification (CPV) program and associated reports, including advanced statistical analysis and data modeling. Support the development of protocols, reports, and data visualizations using tools such as JMP and LIMS. Facilitate and chair Signal Escalation Board meetings, driving cross-functional decision-making and continuous improvement. Track and manage CAPAs, deviations, and effectiveness checks, ensuring closure and compliance. Support the design and execution of Analytical Method Performance Monitoring (AMPM) program and associated reports, including advanced statistical analysis and data modeling. Mentorship and Cross-Functional Leadership Mentor and train MS&T team members and cross-functional partners in compliance best practices, data analysis, and regulatory expectations. Facilitate cross-departmental projects, fostering collaboration and knowledge sharing. Serve as SME for GxP, ICH, and other regulatory guidelines, providing guidance on interpretation and application. Participate in scientific conferences if requested. Strategic Initiatives Identify and drive process improvements, leveraging Lean/Six Sigma or similar methodologies. Represent MS&T Compliance in organizational initiatives and external partnerships. Apply statistics for analytical chemistry, data trending, out of specification data, and method development and validation. Perform risk assessments for supplier and compendial changes. Serve as a project lead with little to no supervision. Introduce new concepts, practices, instrumentation, techniques, and methodology that can be leveraged to solve current research questions. Advise senior management on project technical details Express scientific creativity in solving current R&D challenges. Perform other related duties as assigned.

Requirements

• Knowledge Experience with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.
• Advanced writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.
• Demonstrated understanding of drug product formulation development.
• Demonstrated understanding of critical quality attributes (CQAs) of drug products based on formulation and stability.
• Skills Experience with the use of electronic document management system(s).
• Extensive experience using word processing, spreadsheet, and database programs.
• Experienced with MS Office.
• Experience with computer systems for sample tracking and raw data handling.
• Advanced proficiency with data analytics tools and process improvement methodologies.
• Demonstrated proficiency with test method development and validation.
• Effective written and oral communication skills.
• Abilities Learn and apply new techniques.
• Ability to present in team meetings.
• Attention to detail.
• Efficient, accurate, and consistent in data compilation and review.
• Work independently and with other analysts, handle multiple projects and timelines concurrently.
• Demonstrate problem-solving in a timely manner.
• Strategic thinking and problem-solving abilities, with a continuous improvement mindset.
• Strong leadership, mentoring, and cross-functional collaboration skills.
• Exceptional organizational, interpersonal, and communication skills, with the ability to influence at all levels.
• Proven ability to manage multiple complex projects, set priorities, and deliver results under tight timelines.
• Bachelor’s or graduate degree in chemistry or related field.
• Ten or more years of related analytical laboratory experience, a minimum of six years in a pharmaceutical environment is preferred, with an emphasis on methods development and validation.

Responsibilities

• Independently develops, tests, validates and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency.
• Mentors less experienced analysts.
• Uses in-house standard operating procedures, compendial documents, industry guidances and pharmaceutical industry knowledge to perform tasks.
• Fosters an environment of safety and company culture.
• Apply and stay current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently.
• Advise on project decisions with potential regulatory consequences.
• Knowledgeable in the execution of compendial methods, specifically USP and EP.
• Complete impact assessments for compendial updates and assist QA Development in initiation of related change controls.
• Assist the Quality Control (QC) laboratory in troubleshooting test method issues.
• Efficiently write, review, and approve technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.
• Adhere to validated test methods, standard operating procedures, and applicable guidance.
• Use technical discretion in designing, executing, and interpreting experiments that contribute to project strategies.
• Serve as contact for vendors and contract laboratories.
• Present supplier notifications and impact assessments to MST Change Control meetings.
• Complete assessments and resulting change actions for supplier items.
• Interact closely with project teams across departments and outside testing laboratories.
• Interpret, review, and discuss data from outside testing laboratories.
• Provide analytical support to Formulation Development and interact with team members in exchanging technical expertise.
• Act as a subject matter expert (SME) in instrumentation, methodology, and guidance.
• Lead communications and strategy for external and internal audits, serving as primary contact for regulatory inspectors and auditors.
• Develop and implement compliance programs, proactively identifying and mitigating risks.
• Lead resolution of complex compliance issues, collaborating with regulatory agencies and internal stakeholders.
• Escalate and manage significant risks, ensuring timely and effective corrective actions Support self-audit efforts and developed strategies for compliance and remediation.
• Act as Training Admin-Assign and verify training for new employees and expedited documents.
• Support the design and execution of Continued Process Verification (CPV) program and associated reports, including advanced statistical analysis and data modeling.
• Support the development of protocols, reports, and data visualizations using tools such as JMP and LIMS.
• Facilitate and chair Signal Escalation Board meetings, driving cross-functional decision-making and continuous improvement.
• Track and manage CAPAs, deviations, and effectiveness checks, ensuring closure and compliance.
• Support the design and execution of Analytical Method Performance Monitoring (AMPM) program and associated reports, including advanced statistical analysis and data modeling.
• Mentor and train MS&T team members and cross-functional partners in compliance best practices, data analysis, and regulatory expectations.
• Facilitate cross-departmental projects, fostering collaboration and knowledge sharing.
• Serve as SME for GxP, ICH, and other regulatory guidelines, providing guidance on interpretation and application.
• Participate in scientific conferences if requested.
• Identify and drive process improvements, leveraging Lean/Six Sigma or similar methodologies.
• Represent MS&T Compliance in organizational initiatives and external partnerships.
• Apply statistics for analytical chemistry, data trending, out of specification data, and method development and validation.
• Perform risk assessments for supplier and compendial changes.
• Serve as a project lead with little to no supervision.
• Introduce new concepts, practices, instrumentation, techniques, and methodology that can be leveraged to solve current research questions.
• Advise senior management on project technical details Express scientific creativity in solving current R&D challenges.
• Perform other related duties as assigned.

Benefits

• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level