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Technical Writer Analytical Chemist, Data Entry

Location:
Saint Paul, MN
Salary:
$18/hour
Posted:
June 29, 2022

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Resume:

GOAL:

To obtain a new position that will provide a challenging opportunity, and will also exercise the skills and experience I have achieved as a pharmacy technician, analytical chemist, technical writer, trainer, and auditor, in a quality-conscious, safety-driven environment.

Authorized to work in the US for any employer

EDUCATION:

Bachelor of Arts in Applied Chemistry with an Emphasis in Biology

Lipscomb University - Nashville, TN

SKILLS Experienced technical writer, trainer, and auditor Strong knowledge of cGXP documentation practices and laboratory techniques 10 years’ experience as an Analytical Chemist in the pharmaceutical/medical device industry . Good communication, organizational, and people skills Proven leadership and mentoring abilities Recognized for instrumentation troubleshooting skills Experienced chromatographer, including HPLC, UPLC, and GC Familiar with ISO 13485, 21CFR parts 11, 210, 211, 820, and USP

WORK EXPERIENCE:

*Study Specialist

WuXi AppTec/Laboratory Staffing – Saint Paul, MN February 2016 to August 2016

Responsibilities:

- Report Writing and Editing for several projects

- Addressing QA 1st and 2nd reviews.

-Amendments: Protocol Amendment, such as changes in Test Article, Product Descriptions, Animal Numbers, and Study Directors; Amended Reports; Cancellation Amendments

-Scanning and Shipping of Final Reports

Update multiple studies Tracking spreadsheets across tests, contributing to constant ability to track study metrics real time.

-Updated Historical Database : Mice/Rats/Rabbits

-Performed Data QC for Custom Studies group

Accomplishments:

–Knowledge of project folder processing from initiation through finalization of reports.

–Proficient in many, some specialized, report components, including, appendices, photographs, figures, special instructions, reviewing and inserting Excel spreadsheets, BSC reports, updating positive control information, shared controls, extra extractions, neat samples, amendments

–Becoming accustomed to finding and addressing Sample Preparation and ILS Technicians to make corrections with associated worksheets and understanding the potential effects of the corrections on the entire testing panel

–Proficient in many different types of reports, such as, GLP, GMP, ISO, USP, and Japanese.

*Creative Team Member

JoAnn Fabrics - Roseville, MN October 2015 to February 2016

Responsibilities: -Customer Service: helped customers with their sewing and craft projects by suggesting ideas, sharing tips and tricks, deciphering instructions on patterns and other projects, and helping them find what they needed in the store.

-Cutting Table: used many math skills to help customers decide how much fabric, batting, foam, or other materials that they needed for their project.

-Cashier: made suggestions regarding what other items customers may need, handled money, credit cards, and coupons,

Accomplishments: -Was an outgoing, positive worker, consistently had customers thank me for my assistance. Went above and beyond to encourage customer to become repeat customers.

Skills: Used Math skills, friendly personality, ability to comprehend and teach complicated instructions, ability to work with a team

*Grade School Volunteer

Vadnais Heights Elementary - Vadnais Heights, MN September 2012 to Present

Responsibilities: - Field Trip Chaperone: go on field trips and help teachers with whatever they need. Some of the places include Museums, Apple Orchards, Plays, and in-school activities

-Tye Dye T-shirt Day: make the die for the tie dying, help the students tie their t-shirts in different ways to make different neat patterns, help the kids tie dye their t-shirts with a team of parents

-MIA Art Adventure Program: take a field trip with other parents to the Minneapolis Institute of Arts to learn how to teach students about art, take the art to the classroom and use pictures and props to teach the kids about each different piece of art

. –Accomplishments: -Fun with kids doing all kinds of things, getting kids involved and excited about learning, being involved and excited about my own kids and their fun and learning in school

l -Skills Used Teamwork/leadership with other parents, chemistry skills and leadership in making dye for tie-dying, personality skills to get students involved in excited about the projects, teaching skills with kid

*Technical Writer

St. Jude Medical/Volt Scientific Staffing - Plymouth, MN September 2012 to April 2013

-Worked on project to update documents into new format and put into Windchill from retiring database system - Worked on project to create new documents to detail step-by-step use of Oracle Clinical database, including screen shots - Mined data for Building 2 pre-validation work. - Created and reviewed Form Packets -Created CR Description and Justifications for MP Change Requests -Revised manufacturing procedures for Atrial Fibrillation Division using Microsoft Word, Adobe Acrobat, and Windchill. -Created documents for Extrusion Line Setup MP for lines 1-3, including photographs

*Technical Writer

Ecolab/Kelly Scientific Staffing - Eagan, MN October 2011 to April 2012

-Authored and revised operating procedures for equipment in the plant at the engineering facility for use at an operator level using Microsoft Word, SnagIt, and photograph software. -Created a slide show to relay training and other important information to the plant employees, who have limited email access. -Helped prepare the plant for an ISO audit. -Worked with a senior operator to audit and update the Lockout Tagout procedures throughout the entire plant.

*Analytical Chemist Contractor

Cargill Health & Nutrition/Volt Staffing - Savage, MN June 2011 to September 2011

-Worked with a team of 4 other chemists to staff the analytical laboratory for a 24/7 pilot plant scale up project -Tested high priority and in-process food additive samples by UPLC and TOC. -Used many types of laboratory instrumentation and technique for solution, standard, and sample preparation, including: pH meter, burette titration, Eppendorf pipetting, anaerobic chamber -Recognized by team members for troubleshooting issues and fixing the UPLC systems - Microbiology duties, including: diluting, plating, counting, and reporting in-process micro samples, as well as, running the autoclave -Member of the Recognition Committee

*R&D Scientific Assistant /Quality System Specialist

Rapid Diagnostek, Inc - Hudson, WI November 2009 to November 2010

-Worked closely with R&D Scientist to perform laboratory procedures related to the development and commercialization of RDI's platform technology -Authored and reviewed SOPs and other documents to implement the beginnings of a quality system at start-up sized company -System Administrator for Acera Innovation Pathway database: Maintained documents, parts, specifications, training, and more -Maintained a safe, stocked, and orderly laboratory

*R&D Chemistry Specialist Contractor

Boston Scientific - Maple Grove, MN April 2006 to September 2006

-Tested combination drug/medical device products for drug ID, content uniformity, and impurities using Waters HPLC and Empower chromatography software -Authored equipment accuracy and calibration documents

*HPLC Chemist Contractor

Medtronic - Fridley, MN September 2005 to January 2006

-Tested combination drug/medical device products for drug ID and release rate using Agilent HPLC and ChemStation chromatography software -Performed internal laboratory audits to aid management in moving a non-cGMP laboratory towards cGMP compliance - Implemented laboratory logbook system -Established ChemStation HPLC processing methods for increased consistency and compliance

*QC Analyst II/III/Supervisor

Protein Design Labs, Inc – Plymouth, MN November 2001 to September 2005

-Authored, revised, and reviewed many types of technical documents, including SOPs, investigations, protocols, specifications, deviations, reports -Performed quantitative and qualitative cGMP stability, in-process, and release testing of monoclonal antibodies and water using HPLC, UV, IEF, cIEF, TOC -Performed/coordinated instrument installation, calibration, qualification, and maintenance -Reviewed final data at a supervisory level, including notebooks, logbooks, lot release, and lot extension -Investigated OOS test results and out-of-calibration instruments, wrote final reports, including CAPA -Implemented a traceable documentation system for the laboratory, to include analyst notebooks, instrument logbooks, and investigations -DCO/ECO experience, both as a user and a reviewer -Trained analysts on test methods, cGMP documentation, notebooks - mentored new employees - Created a "cGMP Practices" training presentation for laboratory personnel -Assisted QA in implementing an electronic documentation system (EDMS) as a Power User -Participated in HPLC and UV method transfers from method validation group to QC group -Served on committee that scheduled and reviewed supplier audits for Raw Materials -Started and served on Preventative Maintenance Team for Waters HPLCs * Excel, Word, PowerPoint, LIMS, Millennium, Empower

*Analytical Chemist

P3 Scientific - Oakdale, MN November 1997 to November 2001

-Performed quantitative and qualitative cGMP stability and release testing of drugs and drug delivery systems using HPLC, GC, Dissolution Baths, UV, IEF, cIEF, KF Titrators, ICP, TOC, and more -Authored, revised, and reviewed many types of technical documents, including SOPs, investigations, protocols, specifications, deviations, reports, and more -Trained analysts on several test methods, cGMP documentation, notebooks, and mentored new employees -Performed regular audits as member of the Safety Committee -Regularly interacted with sales and technical support personnel from suppliers of instruments, equipment, and materials -Assisted scientist with method validation work -Excel, Word



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