Trachelle Clark
Arvada,CO
Summary
Pharmaceutical and Medical Device Quality and Compliance Professional with a firm working knowledge of cGMP regulations, ICH standards, and USP requirements. Clear demonstration of increasing responsibilities throughout 20 - year career leading organizations in development, implementation, and operational support ensuring efficient quality systems that demonstrate compliance with regulatory requirements. Recognized for building and managing effective and reliable teams that meet deliverables on time. Key skills include: Building rapport and working in teams Effective oral and written communication Proficient with Microsoft Office: Word, Excel, Visio, PowerPoint In-depth working knowledge and interpretation of cGMP requirements and industry standards: US FDA 21 CFR Part 11, 210, 211, 820, and, ICH, USP, and ISO 13485
Overview
29
29
years of professional experience
Work History
Quality Assurance Director
Kromatid, LLC.
Longmont, CO
03.2023 - 06.2023
- Mentored the new employees regarding regulations and compliance
- Audited standard Operating Procedures (SOP’s) to bring them into compliance and worked closely with the VP of Operations to obsolete SOP’s, which resulted in a 30% improvement of the existing Quality System.
Senior Quality Assurance Manager
Brickell Biotech
Boulder, CO
10.2021 - 09.2022
- Served as the Quality representative for Brickell, a clinical phase virtual pharmaceutical company, with responsibility for developing scale and phase-appropriate quality systems and leading quality oversight of contracted service providers in the US, Canada, and China including quality agreements, master batch records, lot release, deviation, change control approvals, and clinical trial materials/product disposition
CEO/Principal Quality and Compliance Consultant
Synergie Compliance Solutions, LLC.
Broomfield, CO
03.2010 - 11.2020
- Contracted by FDA-regulated manufacturing firms as a resource for clinical and commercial quality systems, product quality, and regulatory compliance needs
- Examples include: Performed worldwide cGMP quality audits and gap assessments for Pharmaceutical, Biologic's, and Medical Device industries with a focus on compliance with GMP, GCP, GLP, USP, and ISO requirements
- Remediation of internally or externally identified areas of cGMP non-compliance
- Verified data for the preparation of CMC sections for license applications
- Prepared organizations for regulatory agency inspections, participated in inspections, collaborated responses with cross-functional teams, and verified the accuracy and completeness of responses
- Authored, or provided final review and approval of quality system and product quality documents
- Worked closely with clients to evaluate and document accurate and complete manufacturing and laboratory investigations, which included root cause analysis, impact assessment, and subsequent CAPA remediation and effectiveness checks.
Director of Regulatory Affairs
INSMED Therapeutic Proteins
Boulder, CO
01.2008 - 01.2009
- Regulatory affairs point of contact and member of the executive leadership team
- Provided regulatory expertise for late-stage product development as related to process control, changes, and scale-up
- Approved product studies in support of regulatory filings
- Identified compliance gaps and remediation's with cross-functional teams.
Director of Quality Systems and Regulatory Affairs
AlloSource
Centennial, CO
11.2006 - 01.2008
- Directed, managed, and improved the quality management system resulting in the demonstration of compliance with regulatory requirements
- Hired, managed, and developed twelve staff members to build out the quality system needed and to resource the department to set and achieve quality objectives on time
- Responsible for all quality decisions for the Utah, Ohio, and Colorado AlloSource facilities
- Led a recall that was reduced to a field alert, by the FDA, based on the thoroughness of the investigation.
Manager of Quality Systems and Regulatory Affairs
Inverness Medical -Thermo Electron, BioStar
Louisville, CO
07.2005 - 08.2006
- Set quality objectives and reported meaningful quality metrics to the Executive Leadership Team
- Maintained and improved the quality system processes to ensure compliance with US FDA Title 21 CFR 820, while managing and training eight quality staff members
- Co-Led the technology transfer for a new product introduction with the Manager of Operations
- Successfully led site remediation teams for the first ISO-13485 inspection, which resulted in the site receiving ISO-13485 certification.
Associate Manager of Plant Quality Assurance
AMGEN
Longmont, CO
01.2003 - 07.2005
- Managed and developed four staff members and 15 dotted line reports responsible for investigating and documenting deviations and CAPA
- Led the investigation review board, collaborated on investigation strategies, reviewed each investigation to ensure compliance with requirements, and was responsible for final approval
- Presented investigations and supporting data to regulators during inspections.
Operations Regulatory Compliance Specialist
AMGEN
Boulder, CO
01.2001 - 01.2003
- Co-hosted AMGENs first FDA inspection that resulted in zero Form 483 observations
- Assessed post-approval product manufacturing changes for filing requirements
- Approved all critical investigations for clarity, completeness, and compliance with the regulations
- Conducted internal quality audits.
Senior Process Control Analyst
Geneva Pharmaceuticals (Subsidiary of Novartis)
Broomfield, CO
01.2000 - 01.2001
Senior QA Compliance Specialist
Geneva Pharmaceuticals (Subsidiary of Novartis)
Broomfield, CO
01.1998 - 01.2000
Supervisor of Investigations and Customer Complaints
Geneva Pharmaceuticals (Subsidiary of Novartis)
Broomfield, CO
01.1996 - 01.1998
Microbiologist and Raw Material Chemist
Geneva Pharmaceuticals (Subsidiary of Novartis)
Broomfield, CO
01.1994 - 01.1996
Education
Bachelor’s Degree - Biology
Metropolitan State University of Denver
01.1994
Skills
- Building rapport and working in teams
- Effective oral and written communication
- Proficient with Microsoft Office: Word, Excel, Visio, PowerPoint
- In-depth working knowledge and interpretation of cGMP requirements and industry standards: US FDA 21 CFR Part 11, 210, 211, 820, and, ICH, USP, and ISO 13485
- Cross-functional team leadership
- Attention to Detail
- Internal Audits
- Audit Coordination
- Risk Analysis and Mitigation
- Project Management
- Regulatory Compliance
- Goals Setting
- Employee Training
- Documentation Review
- Continuous Improvement
- Systems Analysis
- QA reporting
- Relationship Building
- Document Control
- Personnel Training
- Employee Supervision
- Complaint Investigation
- Best Practices
- System Development
- Quality assurance experience
- Team Mentoring
- Knowledge of auditing systems
- Work Planning and Prioritization
- GAMP systems expert
- Operation Monitoring
- Policy Reinforcement
- Budget Management
- Agile Methodologies
- Defect tracking
- Inspection Preparation
Websites
Continuingeducation
- ASQ Certified Quality Auditor and Certified Quality Engineer Coursework
- Investigations and CAPA
- Supplier Quality Management
- Quality Auditing
- Change Management
- Navigating Conflict and Managing Difficult Employees
- Situational Leadership, Organizational Behavior, and Managing Competing Priorities
Accomplishments
- Collaborated with team of [Number] in the development of [Project name].
- Achieved [Result] by completing [Task] with accuracy and efficiency.
- Achieved [Result] through effectively helping with [Task].
- Documented and resolved [Issue] which led to [Results].
Timeline
Quality Assurance Director
Kromatid, LLC.
03.2023 - 06.2023
Senior Quality Assurance Manager
Brickell Biotech
10.2021 - 09.2022
CEO/Principal Quality and Compliance Consultant
Synergie Compliance Solutions, LLC.
03.2010 - 11.2020
Director of Regulatory Affairs
INSMED Therapeutic Proteins
01.2008 - 01.2009
Director of Quality Systems and Regulatory Affairs
AlloSource
11.2006 - 01.2008
Manager of Quality Systems and Regulatory Affairs
Inverness Medical -Thermo Electron, BioStar
07.2005 - 08.2006
Associate Manager of Plant Quality Assurance
AMGEN
01.2003 - 07.2005
Operations Regulatory Compliance Specialist
AMGEN
01.2001 - 01.2003
Senior Process Control Analyst
Geneva Pharmaceuticals (Subsidiary of Novartis)
01.2000 - 01.2001
Senior QA Compliance Specialist
Geneva Pharmaceuticals (Subsidiary of Novartis)
01.1998 - 01.2000
Supervisor of Investigations and Customer Complaints
Geneva Pharmaceuticals (Subsidiary of Novartis)
01.1996 - 01.1998
Microbiologist and Raw Material Chemist
Geneva Pharmaceuticals (Subsidiary of Novartis)
01.1994 - 01.1996
Bachelor’s Degree - Biology
Metropolitan State University of Denver
Similar Profiles
Jordan WhislerJordan Whisler
Finanical Analyst and Staff Accountant at KromaTiD, Inc.Finanical Analyst and Staff Accountant at KromaTiD, Inc.
Stacey MangumStacey Mangum
Store Manager at Gunsmoke Firearms LLC Formerly Hi-Caliber LLCStore Manager at Gunsmoke Firearms LLC Formerly Hi-Caliber LLC
Emma LuvianoEmma Luviano
Billing Manager at KDT LLC & KIDS DC, LLCBilling Manager at KDT LLC & KIDS DC, LLC
Angela Kennedy DibalaAngela Kennedy Dibala
Admission Specialist – Military Enrollment Team at University of Arizona Global CampusAdmission Specialist – Military Enrollment Team at University of Arizona Global Campus
Alex KimataAlex Kimata
Senior Associate at Holland & Hart LLPSenior Associate at Holland & Hart LLP