Nicole Heisel
QA Operations Lead at Cambrex | Sioux Falls, South Dakota, United States
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Nicole Heisel serves as the QA Operations Lead at Cambrex, where she leverages her extensive background in microbiology to enhance quality assurance processes within the pharmaceutical manufacturing sector. With a robust history of working in environments regulated by the FDA, USDA, and other oversight bodies, Nicole is adept at navigating the complexities of compliance with cGMP, GLP, and ISO 9001 standards. Her role is pivotal in developing and maintaining quality systems that not only support daily manufacturing operations but also ensure that product and process quality metrics are consistently met.
At Cambrex, Nicole is actively involved in key projects that focus on optimizing quality assurance protocols and conducting thorough area inspections prior to solids charging to vessels and heel removal from filters. Her expertise in Out of Spec Investigations (OOSI) and internal investigations allows her to effectively manage deviations and implement corrective actions that uphold the integrity of the manufacturing process. Collaborating closely with cross-functional teams—including operations, technical support specialists, and business unit leaders—Nicole ensures that quality assurance is integrated seamlessly into the operational workflow.
Her skills extend beyond traditional quality assurance practices, encompassing research and development (R&D) methodologies, food safety protocols, and laboratory animal handling, which are crucial for the development of animal vaccines and human biotherapeutics. Nicole’s commitment to excellence in quality assurance not only safeguards product integrity but also enhances the overall efficiency of Cambrex’s manufacturing operations, making her an invaluable asset to the organization.
QA Operations Lead at Cambrex in October 2022 to Present
Quality Assurance Associate at SAb Biotherapeutics in April 2021 to October 2022
QA Compliance Specialist (QA Tech IV) at Orion Food Systems in August 2019 to April 2021
Manager at Dakota Grills Catering LLC in December 2017 to July 2019
QA Technician at Orion Food Systems in December 2016 to November 2017
Elite Customer Service Representative - CO5 Position at Citi in November 2015 to November 2016
Temp Worker - R&D ELISA at Novartis in April 2016 to May 2016
Collector I at Wells Fargo in March 2015 to November 2015
Analytic Lab Manager at Aquatech Bioenergy LLC in January 2011 to July 2014
GRA (Dr. Gibbons) / GTA (BIO-151L/153L and MICR-231L) at South Dakota State University in September 2007 to May 2012
Quality Scientist I at Fort Dodge Animal Health in September 2004 to June 2007
QC Technician - Animal Testing at Novartis in June 2004 to July 2004
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South Dakota State University, Bachelor of Science (B.S.), October 2026
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Analytical Method Transfer
Clean Rooms
Quality Assurance Analysis
Quality Assurance Standards
Finished Goods
Cleaning Validation
Document Review
FDA GMP
Cross-functional Coordination
Manufacturing Scale-up
Out of Spec Investigations (OOSI)
Change Controls
Summary Reports
Employee Training
University Teaching
U.S. Department of Agriculture (USDA)
U.S. Food and Drug Administration (FDA)
Quality Assurance (QA)
Quality Control (QC)
Research and Development (R&D)
Good Laboratory Practice (GLP)
Good Documentation Practices (GDP)
Good Manufacturing Practice (GMP)
Standard Operating Procedure (SOP)
Data Analysis
Deviations
Corrective and Preventive Action (CAPA)
Change Control
Pre-op / Op Inspections
Product Hold / Reject
Environmental Monitoring
Management
Food Safety
Complaint Management
ICP
Ion Chromatography (IC)
High-Performance Liquid Chromatography (HPLC)
IOPQ (IQ, OQ, & PQ)
Internal Audits
Internal Investigations
metal detector verification checks
Raw Material Release
Label Review
ServSafe Food Manager
Fluorescence Microscopy / Fluorescence Antibody (FA)
Growth Promotion / Cell Culturing
Laboratory Animal Handling (Mice, Hamsters, Rabbits, Guinea Pigs, Pigs, etc.)
Microsoft Office
Redzone
Animal Handling
Animal Testing
Animal Euthanasia
ELISA
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Discover more about CambrexWhat is Nicole Heisel email address?
Email Nicole Heisel at [email protected], [email protected] and [email protected]. This email is the most updated Nicole Heisel's email found in 2026.
What is Nicole Heisel phone number?
Nicole Heisel phone number is 3034647862, 4142138527, 6053239589 and 5859442515.
How to contact Nicole Heisel?
To contact Nicole Heisel send an email to [email protected], [email protected] or [email protected]. If you want to call Nicole Heisel try calling on 3034647862, 4142138527, 6053239589 and 5859442515. (updated on January 05, 2025)
What company does Nicole Heisel work for?
Nicole Heisel works for Cambrex
What is Nicole Heisel's role at Cambrex?
Nicole Heisel is QA Operations Lead
What industry does Nicole Heisel work in?
Nicole Heisel works in the Pharmaceuticals industry.
Nicole Heisel Email Addresses
Nicole Heisel Phone Numbers
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