Brandi L. Howell
Summary
Dedicated quality assurance auditor specializing in compliance assessments and audit facilitation. Proven ability to interpret regulations, conduct thorough audits, and develop actionable corrective plans, ensuring organizational adherence to quality standards and regulatory requirements.
Overview
1
1
Certification
22
22
years of professional experience
Work History
Senior Quality Assurance Auditor
IQVIA (formerly Q Solutions)
Ithaca, NY
10.2022 - Current
- Conduct quality assurance activities and projects for clients, ensuring adherence to departmental and customer policies while effectively scheduling, conducting, reporting, and closing audits within budget and timelines.
- Plan, schedule, conduct, report and close audit activities. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Interpret and consult with project teams on regulations, guidelines, compliance status, and policies to enhance understanding and adherence.
- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
- Prepare and review and approve corrective action plans.
- Host customer audits and mock regulatory inspections, facilitating regulatory facility inspections to ensure preparedness and compliance.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Assist in the training of new Quality Assurance staff.
Quality Assurance Auditor 2
Q Solutions
Ithaca, NY
12.2019 - 10.2022
- Plan, schedule, conduct, report and close audit activities. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Q Solutions SOPs and project-specific guidelines/instructions for clinical and non-clinical studies.
- Conducted quality assurance activities and projects for clients, ensuring adherence to departmental and customer policies while meeting budget and timeline requirements for audits.
- Assisted in hosting customer audits and regulatory inspections.
- Assisted in preparing and reviewing corrective action plans to ensure timely resolution of compliance issues.
- Advised management on system audit needs and reported quality compliance issues to facilitate informed decision-making.
- Represented quality assurance program during customer and project meetings.
- Enhance and maintain a working knowledge of relevant GXP regulations.
Quality Assurance Manager (Medical Devices)
CPSI Biotech
Owego, NY
04.2018 - Current
- Act as the development liaison with a medical device consulting firm to develop and implement a Quality Management System that meets the requirements of the international standard ISO 13485:2016 and U.S. QSR (21 CFR 820).
- Directed the strategy, administration, and direction of the Quality Assurance organization.
- Led risk management activities across product lifecycle, ensuring compliance and safety during new product development and postproduction phases.
- Functions as an integral member of new product development teams and is responsible for ensuring compliance during the design control and design transfer processes.
- Participate in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
- Developed internal procedures, including Quality Assurance Techniques, enhancing compliance across R&D Engineering, Safety, Operations, Finance, Quality, and Life Science.
- Approved documents that supported design control, including drawings, part numbers, specifications, control strategy documents, stability protocols, plans, and reports.
- Provided actionable feedback during management reviews, facilitating strategic improvements aligned with organizational goals.
- Serve as the management representative for regulatory inspections and communication.
Quality Product Manager
X-Gen Pharmaceuticals Inc.
Horseheads, NY
11.2012 - 04.2018
- Managed Quality Assurance aspects of multiple new drug products from initial development through FDA regulatory submittal to market launch.
- Oversaw product life cycle management for multiple products in commercial pipeline, including stability protocols, data from contract laboratories, specifications, manufacturing batch records, change controls, and associated reports.
- Managed pharmacovigilance, adverse events, and customer complaints to ensure compliance and product safety.
- Coordinated communication and activities for an X-Gen product recall, ensuring timely resolution and regulatory compliance.
- Traveled to customer sites for quality visits during manufacture of registration batches. Audited CMOs and API suppliers.
- Ensured that current compendia & regulatory documents (FDA, USP, CFRs and EP) and supplements are maintained for product portfolios.
- Managed cross-functional groups for the purpose of conducting an internal Annual Product Review (APR) for all X-Gen commercialized products.
Chemist
X-Gen Pharmaceuticals Inc.
Horseheads, NY
03.2011 - 11.2012
- Developed and revised SOPs and test methods for QA/QC department, enhancing operational consistency and compliance with regulatory requirements.
- Maintained stability program and performed routine stability testing for assigned projects.
- Coordinated method transfers for new products, preparing transfer protocols and documentation to ensure compliance and smooth implementation.
- Managed hazardous waste storage and disposal for QC laboratory, ensuring adherence to safety regulations and environmental standards.
- Prepared COAs, test memos, Quality Assurance Techniques and other pertinent laboratory documentation.
- Reviewed and prepared specific product batch record materials for final release.
- Revised SOP and associated regulatory and customer forms as a member of the Recall Team.
- Audited customer sites and assisted in the preparation of final audit reports for management.
Finished Product / Stability Manager
Norwich Pharmaceuticals Inc.
Norwich, NY
01.2009 - 08.2010
- Supervised and led the stability and finished product testing group within the QC laboratory.
- Chemical and physical analyses were performed in support of raw material, finished product and stability testing.
- Led the laboratory investigation processes as a lead laboratory investigator (LIR, QVR, NOI, IR) by coordinating efforts and following established SOPs.
- Identified, developed, and executed corrective and preventative action plans (CAPA) in response to inspection and audit findings.
- Coordinated cross-departmental efforts to align site quality objectives with departmental goals.
- Forecasted resource loading and managed resource allocation to support projects.
- Ensured that chemists were working to support projects, customer complaints, and manufacturing issues.
- Provided technical leadership while working to understand training gaps to further develop training initiatives.
- Led waste reduction initiatives in QC laboratory through contributions to Lean Six Sigma and Kaizen events.
Chemist II Project Leader
Norwich Pharmaceuticals Inc.
Norwich, NY
07.2005 - 01.2009
- Coordinated method transfers, method validation, release, stability and cleaning verification/validation testing with QC team members.
- Technical skills included use of balances, pH meters, FTIR, HPLC, UV-Vis, Dissolutions, KF, and other wet chemistry techniques.
- Authored and participated in laboratory investigations for out-of-specification and out- of-trend results. Communicated findings of the subject incident to clients and worked to resolve issues promptly.
- Mentored new hire employees within the group and coordinated training on techniques and methods. Educated and monitored the progress of new chemists on laboratory systems, safety, and compliance.
- Identified 8 types of waste in QC laboratory; developed and implemented processes to reduce or eliminate waste.
- Facilitated TotalChrom support to improve data management in the QC lab. Assisted method development team to streamline data acquisition and reporting for the QC laboratory.
- Served as system owner by overseeing maintenance and functionality of laboratory instruments. Performed preventative maintenance on key instrumentation within the QC laboratory. Maintained accurate records utilizing laboratory notebooks and SAP; all assignments were following cGMP/cGLP.
Assistant Scientist
Abbott Laboratories
Abbott Park, IL
05.2004 - 05.2005
- Supported senior scientists in developing and validating analytical methods using LC-MS, enhancing drug analysis processes.
- Performed analyses of drug concentrations in various biological matrices.
- Prepared product samples, processed raw data, and developed protocols and reports to ensure compliance with regulatory standards.
- Executed daily instrument calibrations, managed laboratory supply inventory, and conducted peer reviews of laboratory notebooks for accuracy.
- Engaged in weekly project status meetings to ensure alignment on objectives and timelines. and educational seminars.
Education
Bachelor of Arts - Chemistry
University at Buffalo
Skills
- Regulatory compliance
- Audit preparation
- Internal auditing
- Quality assurance systems
- Corrective action plans
- Risk assessment
- Process improvement
- Documentation review
- Quality management systems
Certification
ASQ, Certified Quality Auditor (2015 - 2024)
Timeline
Senior Quality Assurance Auditor
IQVIA (formerly Q Solutions)
10.2022 - Current
Quality Assurance Auditor 2
Q Solutions
12.2019 - 10.2022
Quality Assurance Manager (Medical Devices)
CPSI Biotech
04.2018 - Current
Quality Product Manager
X-Gen Pharmaceuticals Inc.
11.2012 - 04.2018
Chemist
X-Gen Pharmaceuticals Inc.
03.2011 - 11.2012
Finished Product / Stability Manager
Norwich Pharmaceuticals Inc.
01.2009 - 08.2010
Chemist II Project Leader
Norwich Pharmaceuticals Inc.
07.2005 - 01.2009
Assistant Scientist
Abbott Laboratories
05.2004 - 05.2005
Bachelor of Arts - Chemistry
University at Buffalo