Jordan Rose
Associate Specialist II - Validation at Emergent BioSolutions- Claim this Profile
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Bio
Credentials
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SOLIDWORKS 2022 Essential Training
LinkedInDec, 2022- Nov, 2024 -
Essential Lessons for First-Time Managers
LinkedInOct, 2022- Nov, 2024 -
Holding Your Team Accountable
LinkedInOct, 2022- Nov, 2024 -
Mindful Working: 11 Ways to Improve How You Work
LinkedInOct, 2022- Nov, 2024 -
Working with High-Conflict People as a Manager
LinkedInOct, 2022- Nov, 2024 -
Be the Manager Who Fights for Their Team
LinkedInSep, 2022- Nov, 2024 -
How to Be Both Assertive and Likable
LinkedInSep, 2022- Nov, 2024 -
Leading and Motivating People with Different Personalities
LinkedInSep, 2022- Nov, 2024
Experience
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Emergent BioSolutions
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Specialist II - Validation
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Dec 2022 - Present
As a Validation Specialist, I am responsible for ensuring compliance with regulatory requirements for new and existing facilities, utilities, and equipment. My role involves:- Developing comprehensive validation strategies and creating project validation plans, as well as robust and efficient test protocols and reports- Estimating validation timelines and resource requirements- Coordinating, communicating, and completing assigned validation tasks- Operating advanced instrumentation to perform environmental monitoring studies, such as temperature and relative humidity measurements- Reviewing User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests for facilities, equipment, and utilities-Authoring documents including procedures, summary reports, and status reports to ensure data integrity as a system administrator for defined computerized systems- Reviewing and approving documents prepared by the validation team, other departments, and contractor organizations while working closely with cross-functional teams- Resolving and assisting in the closure of deficiencies and deviations initiated during validation activities, as well as those related to critical process parameters- Assisting in the implementation of existing validation programs to ensure continued compliance with necessary regulations- Participating in audit interviews and supporting audits conducted by regulatory agencies Show less
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Analyst III - Quality Control Raw Materials
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Sep 2021 - Dec 2022
- Write studies and reports to support investigations, supplier qualifications, and validation/verification studies.- Perform preventative maintenance and calibrations on complex laboratory equipment in accordance with established procedures.- Demonstrate advanced proficiency in the use and maintenance of laboratory equipment, and perform training to educate others.- Plan and execute experimental tasks, including obtaining and interpreting experimental results.Identify opportunities for improvements within quality control (QC) procedures and documentation.- Identify patterns and trends, troubleshoot abnormalities, and investigate problems related to QC procedures and documentation.- Execute development and validation studies, and write protocols and reports.- Review and provide feedback on protocols and reports prepared by other team members. Show less
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Analyst II - Quality Control Raw Materials
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Jan 2020 - Aug 2021
- Perform a wide variety of analytical and compendial methodologies such as FTIR, Refractometry UV-VIS, titrations, and Gas Chromatography- Work productively with other team members as well on independent assignments- Communicate professionally, verbally and in writing, with collaborators and external departments- Train and aid junior staff in progressing through their goals- Execute on development and validation studies; Assist in leading quality testing- Write protocols/reports; review and provide feedback- Guide project progression through appropriate decision making- Assist in on-boarding new analysts through the ‘Buddy Up!’ Program- Coordinate Water’s, and Mandel contractors for yearly calibration and PM’s Show less
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Analyst I - Quality Control Raw Materials
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Apr 2018 - Dec 2019
- Perform routine laboratory procedures including analyzing and reviewing data- Receive, prepare, test, release materials used for QC testing, and manufacturing use- Document laboratory work consistent with GxP requirements- Maintain laboratory records and inventory for supplies, standards, and reagents- Perform preventative maintenance on laboratory equipment- Complete purchase requisitions for materials and services in SAP- Coordinate Outside Testing samples and documents- Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures- Adhere to all effective STM’s/SOPs and safety requirements Show less
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Parrish & Heimbecker, Limited
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Canada
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Food Production
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200 - 300 Employee
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Lab Technician Assistant – Quality Control
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Aug 2017 - Apr 2018
- Deoxynivalenol and Ochratoxin A testing - Perten Falling Number Method - FOSS Protein/Moisture/Oil Preparation - Grain Grade input - Barley germination testing - Deoxynivalenol and Ochratoxin A testing - Perten Falling Number Method - FOSS Protein/Moisture/Oil Preparation - Grain Grade input - Barley germination testing
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Education
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2012 - 2017
The University of Winnipeg
Bachelor of Science - BS, Neuroscience -
2011 - 2012
University of Manitoba
Bachelor of Science - BS
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