CECILIA COLEMAN
Pflugerville,TX
Summary
Detail oriented team player with 13 years of experience as a Chemist and Quality Assurance Specialist in the pharmaceutical and medical device industries.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Quality Systems Engineer
Artivion Inc. (Heart Medical Devices)
07.2022 - Current
- Responsible for operating the Quality Management System
- Assisted in providing assurance the company operates in compliance with all required regulations and standards (ISO 13485 and applicable standards)
- Facilitated training and championed the Quality Management System
- Ensured Corrective/Preventive Action (CAPA) and Audit Program requirements comply with applicable requirements
- Coordinated and authored investigations and ensured timely closure
- Coordinated and completed management review, nonconformances, quality planning and change control
- Conducted internal audits and assisted in agency and BSI certification audits.
Process Improvement Specialist
Benuvia Manufacturing (Syndros, Subsys, Drug Product Development and Manufacturing)
09.2021 - 07.2022
- .Investigated all manufacturing deviations and implemented corrective/preventive actions
- Assisted Management to identify gaps in the process and implement process improvements by editing batch records, SOP’s, or applicable documents
- Communicated with customers on gaps needing to be addressed
- Developed and maintained a list of ongoing Process Improvement projects and tracked them.
QA Manager
Benuvia Manufacturing (Syndros, Subsys, Drug Product Development and Manufacturing)
04.2021 - 08.2021
- Provided Quality oversight to all aspects of the manufacturing activities involving API and finished dosage
- Approved GMP documentation including batch records, SOP’s, raw materials, Room release
- SOP and batch record review edit
- Authored, reviewed, and approved investigations for Manufacturing and Quality Control Lab
- Implemented corrective/ preventive actions
- Supervised and Trained personnel (3) for batch record release, documentation and room clearance
- Performed internal audits and vendor audits for qualification as new supplier
- Assisted in FDA audit.
Data Reviewer Specialist
Molecular Templates (Engineered Toxin Bodies, Cancer Therapies)
04.2020 - 03.2021
- Created COA's and released all batch records including technical review of all testing submitted for approval
- Initiated investigations and assigned corrective/preventive actions.
Senior Analyst III
ICU Medical (IV Bags Manufacturing Plant)
04.2019 - 04.2020
- Conducts routine testing for Resin Blending Lab film and commodity constituents
- This includes Karl Fisher, UV-His, HPLC, pH, Total Organic Carbon, fractional distillations, etc
- Leads and schedules analysts to prioritize and perform testing
- Investigates deviations (CAPAs and LIR's) in Agile to root cause and assigns corrective/preventive actions
- Assists with validations by executing and or acting as a Subject Matter Expert in test methods
- Writes and edits Standard Operating Procedures for continuous improvements in the lab
- Provided On the Job (OJT) Training to incoming Plastics Chemists.
Quality Engineer I- Complaints
ICU Medical (IV Bags Manufacturing Plant)
01.2018 - 04.2019
- Conducted routine investigations of Customer complaints and established corrective and preventive actions for any manufacturing related events
- Responsible for Field Alert Response (FAR) coordination and Site Quality Review Team (SQRT) for escalated investigations
- Quality Management Review Data Analysis of all Complaints
- Provides responses for Site Supplier Corrective Action Requests (SCARs)
- Provides Annual Product Quality Review (APQR) data for review of FARs, recalls and safety warning notifications.
Data Verification Specialist (Quality Control)
ICU Medical (IV Bags Manufacturing Plant)
04.2016 - 01.2018
- Batch Record Auditor who ensured compliance of testing with all USP, EP, JP regulations enforced by the FDA in a GMP facility
- Ensures compliance and timely release of product to include In-Process, API, Final Product, and Plastic Materials
- All final approval is performed by Data Verification Specialist
- Responsible for identifying deviations, errors in documentation, instrument audit, and all other compliance issues
- Responsible for continuous improvement in the lab to ensure right the first-time batch records
- Trackwise reports generator to ensure no investigations are holding product for release
- Responsible for initiating deviations in the Trackwise system if necessary
- Continuous improvement driver.
Chemical Analyst I and II
Hospira (IV bags)- a Pfizer Company
02.2011 - 04.2016
- Responsible for HPLC, wet chemistry, UV-vis, TOC, polarimeter, pH, conductivity, turbidity, X-ray, AA, pipetting, among many tests while following GLP in a GMP manufacturing plant
- Obtained Qualified Fellow Employee (QFE) certification within one year of employment to train new analysts
- Ensured In-Process Chemistry (IPC) batch record completeness for timely release of product as team lead
- Updated the training curriculum to maintain compliance with the most recent FDA regulations
- Authored and maintained SOPs for the safe storage of laboratory chemicals and testing of raw materials
- Recommend and/or executed corrective and preventive actions (CAPAs) for out-of-specification (OOS) investigations
- Commissioned an X-Ray instrument for Zinc analysis in plastics for IV bags (validation)
- Validated new FTIR software for the Resin Blending Laboratory
- Performed routine testing for In-Process Chemistry Lab, and Resin Blending Lab (Plastics) to include pH, titrations, Karl Fisher, arsenic, film testing
- TOC, Atomic absorption, X-ray, HPLC, etc
- Became certified to become official trainer for all incoming Analytical Chemists
- Ensured Chemists could perform all testing by performing, shadowing and then completing on their own
- SME for In-Process Chemistry and Resin Blending Lab during FDA audits.
Warehouse Specialist
DZSP-21
02.2009 - 11.2009
- [Material Supply contract company for USAF] Interim Secret Security Clearance gained as a civilian contractor
- Put Away, processed, and maintained critical Air Force parts for the planes at Andersen Air Force Base, Guam
- Supported the Andersen Air Force Base mission by providing after hours support to the B-52 planes, and any highly critical airplane parts that needed to be shipped out
- Secured many parts worth many millions of dollars at night with no supervision needed (was the only civilian on this shift with the military personnel.) Learned the AF-MAN 23-110 (Air force manual) in a very short amount of time to follow all the regulations
- Maintained the shelf-life program for all perishable parts and ensured they were properly trimmed
- Trained in several departments of the contract (Individual Equipment Uniforms, Receiving and Storage)
- OSHA Training gained to handle highly hazardous materials
- Raymond Forklift Training, Safety Training, Information Awareness Safety, and Air Force Supply computer software.
Education
B. A. Chemistry -
University of Guam
Mangilao, Guam12.2008
Skills
- Excel
- Microsoft Word
- Sharepoint
- Teams
- Webex
- SmartSolve
- Trackwise
- LIMS
- Master Control
- Six Sigma Methodologies
- Lean manufacturing techniques
- Testing Coordination
- CAPAs/SCARs
- Document Management
- Compliance
- Process Improvement
- Report Preparation
References
References available upon request
Certification
ASQ Certified Quality Auditor (December 2023)
ASQ Root Cause Analysis
Timeline
Quality Systems Engineer
Artivion Inc. (Heart Medical Devices)
07.2022 - Current
Process Improvement Specialist
Benuvia Manufacturing (Syndros, Subsys, Drug Product Development and Manufacturing)
09.2021 - 07.2022
QA Manager
Benuvia Manufacturing (Syndros, Subsys, Drug Product Development and Manufacturing)
04.2021 - 08.2021
Data Reviewer Specialist
Molecular Templates (Engineered Toxin Bodies, Cancer Therapies)
04.2020 - 03.2021
Senior Analyst III
ICU Medical (IV Bags Manufacturing Plant)
04.2019 - 04.2020
Quality Engineer I- Complaints
ICU Medical (IV Bags Manufacturing Plant)
01.2018 - 04.2019
Data Verification Specialist (Quality Control)
ICU Medical (IV Bags Manufacturing Plant)
04.2016 - 01.2018
Chemical Analyst I and II
Hospira (IV bags)- a Pfizer Company
02.2011 - 04.2016
Warehouse Specialist
DZSP-21
02.2009 - 11.2009
B. A. Chemistry -
University of Guam
ASQ Certified Quality Auditor (December 2023)
ASQ Root Cause Analysis
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