Monica Pavlack
Summary
Detail-oriented Technical Writer with expertise in GMP environments, focused on creating and updating manufacturing documents for regulatory compliance. Led cross-functional initiatives to enhance operational quality through validation protocol development. Extensive experience in document editing and distribution, supporting biomanufacturing objectives with precise and compliant documentation.
Overview
12
12
years of professional experience
Work History
GMP Technical Writer
MilliporeSigma
08.2022 - Current
- Created master manufacturing formulations for commercial and clinical products in facility.
- Revised formulations to meet current standards and good documentation practices, enhancing regulatory compliance.
- Updated formulations to support closure of deviations, CAPAs, and change controls, ensuring documentation integrity.
- Edited formulations for accuracy and proofread documents to ensure compliance and clarity.
- Collaborated with cross-functional teams to ensure precise and clear formulation documentation.
Process Validation Scientist
ThermoFisher Scientific
02.2021 - 07.2022
- Authored validation protocols for PPQ runs to enhance operational compliance.
- Executed validation protocols, reports, and SOPs to ensure compliance with company policies.
- Investigated data process deviations and resolved quality issues effectively.
- Summarized and evaluated protocol data, verifying accuracy and addressing discrepancies.
- Collaborated cross-functionally on CAPA initiatives and projects to drive improvements.
- Engaged with clients to strategize and align future PV studies with their objectives.
Graduate Research Assistant
Saint Louis University
07.2018 - 12.2020
- Assisted in developing antisense oligonucleotides targeting GRN mRNA, advancing research for frontotemporal dementia.
- Executed DNA/RNA isolation and cell culture using aseptic techniques.
- Conducted analytical assays including ELISA, Western blot, and sample preparation.
- Created research protocols that enhanced study design and ensured rigorous experimentation.
- Cultivated strong interpersonal communication and presentation skills to facilitate effective collaboration in research projects.
- Implemented lab safety protocols to ensure a secure working environment.
Lab Assistant
Ferris State University and Shimadzu Core Laboratory
08.2016 - 06.2018
- Collaborated with faculty to support research initiatives and analyze data, contributing to informed decision-making and project advancement.
- Maintained analytical chemistry instruments through routine checks and parts replacement to ensure optimal performance.
- Prepared buffer solutions for various laboratory equipment to facilitate accurate and reliable experimental results.
- Documented operational recipes on instruments for project execution.
Research Associate
Michigan EPA and USEPA
01.2015 - 06.2018
- Conducted water quality studies for Michigan EPA and US EPA on recreational waters, contributing to environmental safety assessments. Analyzed microbial pathogens to identify contamination sources and recommend targeted mitigation strategies. Performed quantitative PCR on all water samples, ensuring reliability of research results.
- Conducted environmental research for compliance with federal and state regulations.
- Analyzed data to assess environmental impacts and support policy development.
- Collaborated with cross-functional teams to address environmental issues effectively.
Education
M.S - Pharmacology and Physiology
Saint Louis University
Saint Louis, MO01-2021
B.S - Biotechnology
Ferris State University
Big Rapids, MI01-2018
Skills
- GMP compliance
- Quality assurance expertise
- Process validation
- Protocol development
- Technical writing
- Data interpretation
- Regulatory compliance
- Data interpretation
- Microsoft Office proficiency
- Content management
- Project coordination
- Cross-functional collaboration
- Vendor collaboration
- Interpersonal skills
- Communication
- Vendor collaboration
Timeline
GMP Technical Writer
MilliporeSigma
08.2022 - Current
Process Validation Scientist
ThermoFisher Scientific
02.2021 - 07.2022
Graduate Research Assistant
Saint Louis University
07.2018 - 12.2020
Lab Assistant
Ferris State University and Shimadzu Core Laboratory
08.2016 - 06.2018
Research Associate
Michigan EPA and USEPA
01.2015 - 06.2018
M.S - Pharmacology and Physiology
Saint Louis University
B.S - Biotechnology
Ferris State University