Quality Control Assurance
Resume:
Chanda R. Ndah
**************@*****.***
Skills Summary
●General, advanced, and specialized laboratory skill sets in pharmaceutical and MedTech methods in ovoculture, tissue culture, live bird work, chemistry, biology, and microbiology
●Validation and maintenance of laboratory equipment and processes in highly regulated industries
●Familiar with and strong understanding of practices with auditors and multiple regulatory agencies
●Laboratory specialist in Quality Control, Quality Assurance, cGMP, and cGDP
●Drafting, organizing, filing, and maintaining documents including medical charting, SOP's, and special testing protocols, instrument validations & qualifications
●Excellent organizational and analytical skills
●Demonstrated strength in leadership of work, projects, and people
●Remarkable soft skills
EDUCATION
Bachelor of Individualized Learning--Primary Focus: Biology, Secondary: Chemistry, Philosophy/Ethics
Viterbo University--La Crosse, WI
Graduated: May of 2007 Dean’s List, Tri Beta, Bio/Chem Club, Tutor
EXPERIENCE
Ethicon—Johnson & Johnson Med Tech via Kelly Services, BPO November 2023 to present
Scientist I
Performs identity, purity, quantitative, and qualitative laboratory test methods in raw materials, along with documentation of testing on controlled documents and multiple software platforms
Assists often in specialized documentation practices, such as periodic reviews, revisions and updates to controlled documents, instrumentation, instrument validations
Reviews material documentation for accuracy and approves usage for raw materials in manufacturing
Skilled understanding of software platforms Adaptiv, Maximo, SAP, LIMS, Summit, ComplianceWire, AdobeSign,and EtQ
Georgia Poultry Laboratory Network (Gainesville, GA) September 2014 to present
Laboratory Technician II (part-time weekend job)
Demonstrates ability to learn new tasks and take on new work quickly and efficiently
●Wide spectrum of specialized skills in poultry biology, virology, serology, and microbiology quantitative and qualitative diagnostic methods
●Demonstrates impeccable time and security management—works alone with no leadership present
Multiple pharmaceutical contract positions May 2021 to November 2022
Quality Control Chemist I at Societal CDMO & Tyson Foods
Qualified to perform LOD, Viscosity, AQL, fill weights, and investigate customer complaints
Tested, handled, and disposed of controlled substances
Familiarity and experience with food science
Quality Control Analyst II at Alexion Pharma.
●Demonstrated strengthened knowledge of microbiologic methods and techniques
●Endotoxin testing, bioburden testing, and PCR
Boehringer Ingelheim--Merial, Inc (Gainesville, GA) October 2013 to April 2021
Technician IV, Team Lead-Quality Control
●Demonstrates proficiency and knowledge in all testing of ovoculture and tissue culture derived, coccidiosis, and PCR testing of avian vaccines per the USDA and 9CFR.
●Specialized skills developed in determining potency, purity, and sterility of bulk fluids/harvests, finished goods, medias, and diluents.
●Superior skills in all microbiology/environmental testing, potency for non-Marek’s products and back up technician for all other testing
●Demonstrates strong leadership, ability to be a team player, great attendance, and having an overall positive attitude even amongst forever change and chaos
●Consistently completes all paperwork, control charts, and the work in a timely, organized, and meticulous fashion
Home Healthcare Technician (La Crosse, WI) Jan 2008 to April 2012
For terminally ill mother and for private company now called Comfort Keepers
Worked with hospice, elderly, disabled, and/or behaviorally challenged clients in their own homes to try to keep them as independent as possible
Prepared meals, cleaned, dispensed prescription and non-prescription medications (including injections), took clients to doctor and therapy appointments, walks and events to help keep their minds active and involved in the community
Followed patient treatment protocol that was individualized per client by head physician
Charted all events at the end of shift to pass onto the next aide
Cryobiology, Inc. (La Crosse, WI) April 2007 to January 2008
Andrology Lead Lab Technician, QA
●Processed donor samples to store cryogenically until product was sold and used
●Managed laboratory quality control, inventory, all paperwork and lab results
●Managed blood sampling of all donors
●Managed potential donor processes for qualification into the program: appointments, interviews, initial and secondary samples, giving results, maintaining and storing records
Gundersen Lutheran Medical Center (La Crosse, WI) July 1997 to December 2006
Radiologist Office Assistant/Radiology Film Library Lead Tech
Assisted radiologists with digital and hard copy outreach clinic readings and communicated protocols and results with radiology technologists and ordering physicians and providers
Leadership and training of all department staff
Assisted radiology Information Technology with training of all staff during transition from physical films to digital radiography
Assisted Health Information Services with introduction and training of all staff on digital charting software
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