Kathy Mitchell - Quality Control Analyst - Trichromatic | Himalayas
KM
Open to opportunities

Kathy Mitchell

@kathymitchell

Experienced Quality Control Analyst with a focus on compliance and improvement.

United States

What I'm looking for

I am looking for a role that values compliance and continuous improvement, with opportunities for professional growth.

I am an experienced Quality Control Analyst with over 10 years of expertise in pharmaceutical manufacturing, specializing in ISO 9001 standards and surfactant manufacturing. My proficiency in scientific methods and laboratory techniques has equipped me with a strong foundation in quality control measures, method development, and validation. I am committed to driving compliance and continuous improvement in laboratory operations, ensuring that all processes meet the highest standards of quality.

In my current role at Trichromatic, I produce scaled batches for client release while ensuring compliance with regulatory standards. I author standard operating procedures and analytical test methods to enhance operational efficiency and collaborate with quality control chemists to generate high-quality analytical data. My previous experience as a Quality Analyst at Ortec Inc. involved executing method development plans and leading training initiatives, which fostered a culture of continuous learning and improvement within the team.

Experience

Work history, roles, and key accomplishments

TR
Current

Quality Control Analyst

Trichromatic

Aug 2022 - Present (2 years 10 months)

As a Quality Control Analyst, I ensure compliance with regulatory standards by producing scaled batches for client release. I author SOPs and analytical test methods, collaborate with chemists, and develop technical reports to support compliance and submissions.

OI

Quality Analyst

Ortec Inc.

Mar 2019 - Mar 2021 (2 years)

In my role as a Quality Analyst, I executed method development plans and validations, provided technical support in the QC lab, and led training initiatives for chemists to enhance operational performance and regulatory compliance.

AL

Lab Technician

Alexium

May 2017 - Mar 2018 (10 months)

In my role as a Lab Technician, I prepared chemical formulations for clients, focusing on flame retardant and water repellent treatments, while documenting and reporting test results.

HE

Lab Technician

Henkel

Jan 2015 - May 2016 (1 year 4 months)

As a Lab Technician, I conducted routine chemical and physical testing of materials and products, reporting results in various data management systems.

CP

Patient Care Technician

CSL Plasma

Apr 2014 - Jan 2015 (9 months)

In this role, I assisted donors and set up plasma equipment, ensuring adherence to SOPs for patient safety and compliance with ISO standards.

RS

Medical Records Clerk

Recruiting Solutions

Dec 2013 - Apr 2014 (4 months)

As a Medical Records Clerk, I organized and maintained patient records, ensuring compliance with legal standards and facilitating easy access for healthcare providers.

Education

Degrees, certifications, and relevant coursework

Benedict College logoBC

Benedict College

Bachelor of Science, Biology

2008 - 2012

Completed a Bachelor of Science in Biology, gaining a solid foundation in biological sciences and laboratory techniques. Engaged in various projects that enhanced understanding of biological processes and scientific research methodologies.

Tech stack

Software and tools used professionally

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