Tanisha B. Daniels
Knightdale
Summary
Dynamic Manager and Lead Investigator at Pfizer with expertise in root cause analysis and investigation reporting. Skilled in utilizing analytical capabilities to enhance CAPA effectiveness through continuous improvement initiatives. Recognized for strong communication and training skills, promoting team development and collaboration across diverse teams.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Manager - Lead Investigator
Pfizer
Sanford
12.2022 - Current
- Utilization of Method I, DMAIC tools (fishbone diagrams, 5 WHYS, process mapping, Logic-Fault Tree, Causal Analysis, Kepner Tregoe), and Pfizer Human Performance tools to perform root cause analysis during investigations.
- Lead and participate in daily triage meetings for the early stages of the investigation process.
- Interact and coordinate with appropriate personnel including internal departments, outside vendors, bacterial/viral development QA, regulatory (US/Japan/EU/China), and Qualified Persons during the investigational process.
- Facilitate cross-functional and cross-site team meetings to resolve investigation issues.
- Assess the impact of events on products, equipment, or processes.
- Determine corrective actions and continuous improvements and assign commitments to facilitate implementation of identified CAPAs.
- Track, trend, and evaluation of previous events and assessment of CAPA effectiveness.
- Draft written investigations to assure clear, concise summaries, product impact assessments, and commitments.
- Collaboration with Quality Assurance (QA) team to resolve investigation comments for closure in a timely manner.
- Supports regulatory and internal audits through the preparation, defense and interaction with auditors for requested investigations.
- Execution and management of multiple investigations at the same time and use of good communication skills to keep customers, peers, and area management up to date with investigation progress.
- Provides leadership, training, and coaching for junior investigators within the team.
- Identified as a Subject Matter Expert (SME) for the site investigations electronic systems (with both QTS and Veeva Vault).
- Lead in continuous improvement initiatives for the investigation process.
- Method 1 Certification for the investigation process (Pfizer)
Investigator II
Biogen
Research Triangle Park
09.2021 - 12.2022
- Conducted Quality investigations for Drug Substances and assisted with Drug Products with a focus on performance improvement and risk reduction, in alignment with Quality Management System requirements.
- Lead and participated in daily triage meetings for the early stages of the investigation process.
- By identifying primary and contributing root causes made recommendations to correct and/or prevent recurrence of complex and/or high impact investigations.
- Documented investigation reports and findings in designated Quality systems.
- Ensured required management and Quality approvals on final investigations while satisfying established due dates.
- Facilitated corrective and preventive action agreement with stakeholders.
- Facilitated internal sharing of investigational findings and risk knowledge. Contributed to metrics related to investigation process and CAPA effectiveness.
- Analytical and Communication skills to provide understanding and resolution of problem areas through Investigations.
- Presentation of investigations during internal and external audits.
Environmental Control Investigator
Pfizer
Rocky Mount
11.2018 - 09.2021
- Identified root cause and corrective action and preventative action (CAPA's) through the investigation process eliminate reoccurrence.
- Performed Investigations in the form of Quality Assurance Reports (QARs), Events, Laboratory Investigation Reports (LIRs) and Readily Assignable Apparent Cause (RAACs) and associated documentation in accordance with site requirements.
- Responsible for reviewing trends of QC investigations to identify areas requiring additional actions.
Quality Investigator/Sample Stability Scientist
Pfizer
Sanford
05.2017 - 11.2018
- Company Overview: (contracted through Eurofins Lancaster Laboratories)
- Identification of root cause through the investigation process with the creation of corrective action and preventative action (CAPA's) to eliminate future recurrence.
- Wrote investigations to assure clear, concise summaries, product impact assessments, and commitments.
- Utilized SAP, LIMS, Data Historian, PDOCS and Sentry/Trackwise to support the investigation process.
- Participated in the team for LIMS implementation.
- Retrieved and staged stability studies.
- Assembly of GMP worksheet packets for stability, specifications and manufacturing data packets and reissuance of worksheets for failed testing.
- Created stability studies and protocols.
- Served as a manual holder for laboratory manuals and replaced Standard Operating Procedure (SOPs) when revised.
- Use of 5S workplace organization methods.
- (contracted through Eurofins Lancaster Laboratories)
Quality Specialist Materials Release/Sample Stability Coordinator
KBI Biopharma
Durham
04.2014 - 05.2017
- Performed compliance review on the following records: batch record (includes onthe-floor review of records); released data, method qualification/validation reports, and development reports.
- Received, approved, and maintained cell banks and process intermediates to be used in the GMP Manufacturing facilities.
- Reviewed and approved Master Batch Records and Solution Records.
- Worked directly with manufacturing, laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
- Reviewed the following equipment-related documentation: qualification protocols, final reports, master specifications and out of calibration reports.
- Participated in and supported client project teams and regulatory audits.
- Conducted internal audits of departments involved in GMP activities and provided guidance for corrective actions.
- Approval and Rejection of incoming raw materials and products for use in manufacturing.
- Reviewed and approved change controls and specifications.
- Evaluated deviations, laboratory investigations, and customer complaints which may have impacted product quality.
- Ensured QA Reserve samples were collected, stored, and inspected as required.
- Ensured that storage and shipping conditions for materials and products were defined and monitored.
- Ensured that products had been produced, tested and checked with appropriate quality standards (including cGMP, regulatory filings and customer requirements).
- Provided and executed process changes for release and use of incoming products and raw materials.
- Successfully coordinated multiple projects for use in production.
- Interpreted data from primary and secondary sources using statistical analysis and provided reports with data.
- Use of 5S workplace organization methods.
Quality Systems Coordinator
Almac Clinical Services
Sanford
10.2011 - 06.2013
- Responsible for the management of the Durham site Livelink, Trackwise, and DocGen systems.
- Managed and monitored the fileplan to ensure correct usage within Livelink.
- Worked with team members to implement the use of COSMOS.
- Performed validation activities to support the release of new systems and changes of existing systems into operational use.
- Performed gap assessments against new and revised Quality Modules, Quality Directives and SOPs at the site which complied with the requirements of Almac's Quality Manual and met all relevant cGMP and regulatory requirements.
- Assisted with development and/or revision of Quality System procedures and processes.
Instructor
Durham Technical Community College
Durham
07.2011 - 10.2011
- Instructor of Career Readiness class (Provided in depth teaching of Science, English and Resume writing).
- Instructor of Bioworks (In depth teaching of Aseptic technique, Gowning Certification and GMP Environmental training).
Microbiologist I
Novartis
Holly Springs
04.2010 - 06.2010
- Company Overview: (contracted through ManPower)
- Assisted with site start-up activities.
- Performed environmental monitoring which consisted of airborne particles which included surface, viable air, and particulate monitoring.
- Performed gas monitoring and facility water collection.
- Performed water testing assays such as TOC, conductivity, endotoxin and bioburden.
- (contracted through ManPower)
Microbiologist Technician
Becton-Dickinson
Durham
02.2009 - 05.2009
- Company Overview: (contracted through Adecco)
- Environmental Monitoring of airborne particles and microbial analysis of plant air.
- Microbial Analysis of Plant Water.
- Prepared Mouse Embryo and Tissue Culture samples for testing.
- (contracted through Adecco)
Quality Supervisor
Talecris
Clayton
07.2007 - 10.2008
- Managed a total of 15-20 employees.
- Ensured all plasma shipments met specifications and requirements as defined in the Donor Center Standard Operations Procedures manual.
- Ensured that samples that were shipped to the testing laboratory were labeled and documented correctly.
- Ensured that all center incidents were properly documented.
- Trended and follow-up on incidents/errors as required and reported on incident trends in monthly staff meetings.
- Ensured that information in the donor record files was complete and accurate.
- Ensured supplies and materials met quality requirements.
- Ensured that the equipment is properly maintained and calibrated.
- Verification of documentation of equipment maintenance and calibration was accurate and appropriately filed.
- Completed Medical Investigation Reports (MIRs) and Deviations to identify Corrective and Preventive Actions.
Quality Associate II
Talecris
Clayton
08.2004 - 07.2007
- Performed Audit of in-house blood plasma pools.
- Performed internal and external blood plasma pool reconciliation.
- Monitored, reviewed and changed circular charts on freezer used for storage of blood plasma pool samples.
- Verified units listed on Notification for Destruction of Plasma (NDP's).
- Audited and released blood plasma vendor batches.
- Managed and maintained databases tracking all quality assessment results for blood plasma.
Associate QA Biologist
Talecris
Clayton
06.2000 - 08.2004
- Performed environmental monitoring which consisted of air viable, surface viable and particulate monitoring.
- Performed plating of swabs collected from production areas for microbial analysis.
- Collected water and clean steam samples for Limulus Amebocyte Lysate (LAL) testing and Microbial analysis using the filtration method.
- Collected Nitrogen gas and compressed air for moisture and microbial testing.
- Tested final products and raw materials for the presence of endotoxin using the gel clot method.
- Testing of washed bottles to monitor microbial growth.
- Calibrated RCS air samplers.
- Collected and tested Biological Indicators for the presence of any contaminants for cleaning validations.
- Performed method validation testing of bioburden samples.
- Created and revised Standard Operating Procedures.
- Performed non-routine testing associated with validation protocols, critical changes, engineering test plans, and non-routine work requests.
- Trained New employees in Environmental Monitoring, Microbial and LAL testing.
Education
Masters - Business Administration
University of Phoenix
12.2004
Bachelor of Science - Biology/Minor Chemistry
South Carolina State University
05.2000
Skills
- Analytical and troubleshooting skills
- Communication and presentation skills
- Root cause analysis and investigation reporting
- Microbiology expertise
- Method validation for bioburden testing
- Auditing and inventory control
- Training and development
Certification
- Method 1 Certification (Pfizer)
Timeline
Manager - Lead Investigator
Pfizer
12.2022 - Current
Investigator II
Biogen
09.2021 - 12.2022
Environmental Control Investigator
Pfizer
11.2018 - 09.2021
Quality Investigator/Sample Stability Scientist
Pfizer
05.2017 - 11.2018
Quality Specialist Materials Release/Sample Stability Coordinator
KBI Biopharma
04.2014 - 05.2017
Quality Systems Coordinator
Almac Clinical Services
10.2011 - 06.2013
Instructor
Durham Technical Community College
07.2011 - 10.2011
Microbiologist I
Novartis
04.2010 - 06.2010
Microbiologist Technician
Becton-Dickinson
02.2009 - 05.2009
Quality Supervisor
Talecris
07.2007 - 10.2008
Quality Associate II
Talecris
08.2004 - 07.2007
Associate QA Biologist
Talecris
06.2000 - 08.2004
Masters - Business Administration
University of Phoenix
Bachelor of Science - Biology/Minor Chemistry
South Carolina State University
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