Melissa Andersen
Mesa,AZ
Summary
Determined Quality Assurance professional with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments, performing non-conformance investigations and implementing corrective actions. Solid interpersonal and collaboration skills. Committed to paying impeccable attention to reviews and auditing procedures.
Overview
21
21
years of professional experience
Work History
Quality Assurance Analyst II
Dexcom
09.2022 - Current
- Generates reports, analyze trends and insights from QA data.
- Identifies risk and evaluates deficiencies while working with internal departments to drive corrective actions
- Executes audits to ensure quality and consistency in manufacturing areas.
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
- Coordinator of NCE, NCMR and CAPA processes
- Organized and maintained work environment to allow for maximum productivity.
Quality Assurance Specialist
Cytiva
01.2022 - 05.2022
- Responsible for ensuring compliance in accordance with documented procedures for all aspects of operations
- Final batch release of intermediate and finished product including document review for adherence to GDP requirements
- Review and approval of deviations and CAPAs using problem-solving tools (5-Why, Cause and Effect, etc.)
- Implemented process improvements to increase productivity in quality assurance operations.
- Assisted with internal audits.
Quality Specialist II
ARUP Laboratories
05.2017 - 07.2021
- Supported continuous quality improvement activities for Transfusion Medicine (lead quality professional onsite)
- Oversaw and performed nonconformance investigations, root cause analyses and CAPAs
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Investigated and wrote blood product deviation reports to FDA
- Wrote equipment validation studies, department SOPs, deviations and performed monthly departmental audits
- Wrote and implemented software validation for TM Master Control FBS deviation form, updated associated procedures and trained department Supervisors and Group Managers
Operations Engineering Senior Stability Coordinator
USANA Health Sciences
05.2013 - 07.2016
- Managed ongoing stability program of dietary supplements, cosmetics and food products
- Prepared stability study protocols according to FDA/TGA guidelines, collected, trend, analyzed study data and wrote interim and final study reports
- Interfaced with different departments to assure ongoing stability processes, drove out of specification investigations, conducted corrective action meetings, and developed stability studies for product registrations
- Oversaw daily tasks, projects and performance reviews of stability technicians
- Internal and external vendor Auditor.
Quality Control Lab Associate III
USANA Health Sciences
01.2007 - 04.2013
- Coordinated, managed and performed raw material, foods and finish tablet releases for QC
- Managed testing/reporting for stability samples and wrote laboratory SOPs
- Managed laboratory equipment calibrations and qualifications
- Performed chemical analysis of raw material and finish products by ICP-MS, HPLC, LCMS, and GC
- Trained analysts and assisted co-workers with method related problems
- Performed out of specification and stability testing
Biology Laboratory Instructor
SALT LAKE COMMUNITY COLLEGE
08.2008 - 12.2009
- Instructed laboratory procedures for Biology/Human Anatomy and Physiology/Botany
- Organized supplies, maintained equipment and prepared laboratory environments for student learning.
- Administered quiz/semester testing and end of semester grades.
Laboratory Technician II
MYRIAD GENETICS
02.2004 - 12.2005
- Performed DNA sequencing of BRCA and MSH6 genes to detect breast and colon cancer in patient samples
- Prepared patient samples for DNA sequencing and consolidation of PCR products
- Processed high volumes of samples with accuracy, efficiency and conveying communication within th team.
Quality Control Microbiology Lab Associate I
USANA Health Sciences
10.2002 - 02.2004
- Performed microbial limit testing of supplements and skin care products
- Isolation of pathogens, yeast & mold and total plate count and prepared media and broth
- Performed cleaning and product validation tests
- Team worker who was able to adapt in highly dynamic and high volume testing environments.
Education
Master of Science - Laboratory Medicine And Biomedical Science
University of Utah School of Medicine
Salt Lake City, UTBachelor of Science - Biology
University of Utah
Salt Lake City, UTAssociate of Science - Chemistry
University of Utah
Salt Lake City, UTSkills
- Analytical Thinking
- Project Management
- Technical Writing
- Organizational Skills and Detail-Oriented
- Calibration/Equipment Validation
- Quality Auditor to 21 CFR, FDA, ISO 15189 and CAP regulations
- Lean Manufacturing
- Data Compilation and Analysis
- cGMP/GLP Knowledge
- Non-Conformance Investigating/Corrective Actions
- Cause and Effect Analysis/CAPA
- Proficient in Excel, Word, Agile, Oracle ERP, LIMS, MasterControl, SalesForce and Reliance
Timeline
Quality Assurance Analyst II
Dexcom
09.2022 - Current
Quality Assurance Specialist
Cytiva
01.2022 - 05.2022
Quality Specialist II
ARUP Laboratories
05.2017 - 07.2021
Operations Engineering Senior Stability Coordinator
USANA Health Sciences
05.2013 - 07.2016
Biology Laboratory Instructor
SALT LAKE COMMUNITY COLLEGE
08.2008 - 12.2009
Quality Control Lab Associate III
USANA Health Sciences
01.2007 - 04.2013
Laboratory Technician II
MYRIAD GENETICS
02.2004 - 12.2005
Quality Control Microbiology Lab Associate I
USANA Health Sciences
10.2002 - 02.2004
Master of Science - Laboratory Medicine And Biomedical Science
University of Utah School of Medicine
Bachelor of Science - Biology
University of Utah
Associate of Science - Chemistry
University of Utah
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