Andrea Carter

Andrea Carter Email and Phone Number

Technical Writing Consultant @ Regeneron
Austin, TX, US
Andrea Carter's Location
Austin, Texas, United States, United States
Andrea Carter's Contact Details

Andrea Carter personal email

n/a
About Andrea Carter

Andrea Carter is a Technical Writing Consultant at Regeneron. She possess expertise in molecular biology, technical documentation, technical writing, validation, change control and 33 more skills. Colleagues describe her as "I consider myself very fortunate to have worked with Andrea for many years at Thermo Fisher Scientific. Andrea is an exceptional technical writer with the ability to adjust her delivery of material, depending on the audience. She works with confidence and promotes her positive work ethic on a daily basis. Her accountability, dependability and attention to detail are a few of the many reasons that Andrea would be an asset to any organization.", "Andrea was Technical Writer for the Thermo Fisher Manufacturing Sciences and Engineering team in Austin and made an immediate positive impact in reducing documentation errors and deviations. She was highly dedicated to this task, worked well with technical and non-technical team members, and was detailed-oriented in her documentation techniques. She displayed a natural ability to take complex technical subject matter and break it down into instructions that users could understand and clearly follow. Additionally, and most importantly for her role in the team, Andrea consistently displayed thorough understanding of advanced molecular biology and chemistry techniques. She developed this technical understanding in her time as team lead of the Nucleic Acid Synthesis and Analysis team. She was an exceptional member of the team and I strongly recommend Andrea as a technical writer and/or laboratory team lead. Doug Howe, Thermo Fisher MSE Team Lead", and "I worked with Andrea for 7 years. During those 7 years, she proved to be an extremely valuable team member. She never hesitated to take the lead on team projects and was always willing to help out fellow team members. Her vast knowledge on laboratory techniques, as well as technical writing, make her an exceptional candidate for any position sought. Every project/task she worked on was done with a high level of detail and exceeded all expectations. She will always be a valuable team member of any team she is a part of."

Andrea Carter's Current Company Details
Regeneron

Regeneron

View
Technical Writing Consultant
Austin, TX, US
Website:
regeneron.com
Employees:
16494
Andrea Carter Work Experience Details
  • Regeneron
    Regeneron
    Austin, Tx, Us
  • Regeneron
    Consultant - Iops Facilities & It
    Regeneron Oct 2023 - Present
    Tarrytown, New York, Us
  • Propharma
    Quality And Compliance Consultant
    Propharma Oct 2023 - Present
    Raleigh, North Carolina, Us
  • Thermo Fisher Scientific
    Clinical/Ivd Technical Writer
    Thermo Fisher Scientific Jul 2021 - Jul 2023
    Waltham, Ma, Us
    Created and edited clinical verification and validation plans and protocols to support development of sample collection and nucleic acid extraction workflows for a variety of regulated markets. Structured clinical study data collection to create uniform data output compliant with QA/regulatory needs for DHF creation and submission. Analyzed laboratory data from R&D colleagues to create verification/validation reports in support of IVD nucleic acid extraction product launches.
  • Molecular Templates
    Technical Documentation Specialist
    Molecular Templates Mar 2020 - Jul 2021
    Austin, Texas, Us
    Created batch record documentation to bring new protein-based cancer therapeutics to manufacture for Phase I clinical trials. Revised existing batch record documentation under continuous improvement initiatives such as error-proofing, preventing deviations, and implementation of design controls.
  • Molecular Templates
    Quality Assurance Specialist
    Molecular Templates Feb 2019 - Mar 2020
    Austin, Texas, Us
    Managed deviation, LIR, OOS, CAPA and CCR quality systems, reviewed records and data for thoroughness and completion, and led weekly update meetings. Tracked and trended systems data for department metrics, process improvements and quarterly management reviews. Generated business partner weekly quality update reports and supported site quality audits.
  • Perkinelmer, Inc.
    Quality Assurance Engineer
    Perkinelmer, Inc. Sep 2017 - Dec 2018
    Shelton, Ct, Us
    Diagnostics (Dx) Market - NGS (Next Generation Sequencing) Support• Managed the site change control and customer complaint systems.• Worked with Operations department to facilitate process improvement and batch record implementation.• Served as QA lead to R&D for transition of NGS library prep product lines to CE-IVD marking.• Provided thorough and timely review and approval of cGMP documents and processes such as validation, change documentation, deviations, investigations, protocols and reports, and procedures.• Provided QA guidance for quality and compliance issues as needed on the manufacturing floor.• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
  • Thermo Fisher Scientific
    Scientist Iii
    Thermo Fisher Scientific Aug 2015 - Sep 2017
    Waltham, Ma, Us
    Manufactured recombinant E. coli proteins using ÄKTA chromatography. Performed quality control analysis using methods such as qRT-PCR, FRET, and SDS-PAGE under ISO 13485 and cGMP/GDP guidelines and other regulatory standards as appropriate.Used Root Cause Investigations to address CAPA findings and prevent future process deviations. Realigned manufacturing schedule and process flow to improve on-time delivery, reduce lead time, and save >$250K in quarterly work order variance. Revised manufacturing & testing protocols to reduce errors, providing process improvement, cost savings, and greater accurac
  • Thermo Fisher Scientific
    Technical Writer
    Thermo Fisher Scientific Feb 2012 - Feb 2015
    Waltham, Ma, Us
    Edited internal end-user documentation for understandability, ease of use, and GDP/cGMP compliance. Revised documentation including SOPs, manufacturing & testing protocols, and troubleshooting/help guides to comply with site style guide. Saved the company $5000+ on each technically complex document, in labor savings and scrap cost reduction. Created documentation plans and coordinated projects to reduce turnaround time, address similar changes across documents, and worked with QA to reduce document-related corrective actions.
  • Life Technologies (Formerly Ambion, Inc)
    Scientist Iii
    Life Technologies (Formerly Ambion, Inc) May 2006 - Feb 2012
    Waltham, Ma, Us
    Formulated and tested reagents and kits for sale to external customers. Screened materials for contamination as well as functional performance. Documented work per ISO and Good Documentation Practices (GDP) standards.Rapidly acclimated to a fast-paced, high workload environment with very little training, and learned dozens of new protocols within several months.Managed junior team members as a team lead and group scheduler, and organized their weekly workload to reduce turnaround time by 2-3 weeks.
  • University Of Chicago Hospitals
    Senior Research Technician
    University Of Chicago Hospitals May 2005 - May 2006
    Chicago, Il, Us
    Developed and implemented molecular biology protocols to investigate antibiotic resistance in methicillin-resistant Staphylococcus Aureus (MRSA). Supervised and trained junior personnel in laboratory techniques and data analysis. Organized and presented data at meetings and for publication in peer-reviewed journals.
  • Abbott
    Associate Scientist
    Abbott Feb 1999 - May 2005
    Abbott Park, Illinois, Us
    Characterized and validated quality control test methods in a Good Manufacturing Practices (cGMP) environment, to qualify reagents for use in immunoassays. Assisted in data collection and analysis for characterization and validation reports for FDA submissions. Created manufacturing and testing documents. Documented bench work in laboratory notebook entries, monthly highlights and investigational reports.
  • Abbott
    Operations Specialist I
    Abbott Jun 1996 - Feb 1999
    Abbott Park, Illinois, Us
    Formulated and tested hepatitis antigens and antibodies in a cGMP manufacturing environment. This included purification of recombinant antigens and monoclonal antibodies from cell cultures, sera and bacterial lysates using fractionation, chromatography, and concentration/diafiltration systems. Supported R&D validations to transfer manufacturing processes from development to production.

Andrea Carter Skills

Molecular Biology Technical Documentation Technical Writing Validation Change Control Gmp Fda Pcr Biotechnology Sds Page Gel Electrophoresis Life Sciences Protein Purification Qpcr Assay Development Sop Western Blotting Real Time Pcr Biochemistry Quality Control Rna Isolation Dna Radioactive Materials Reverse Transcription Technology Transfer Proofreading Hplc Chromatography R&d Protein Chemistry Bacterial Culture Northern Blotting Rnai Polymerase Chain Reaction Research And Development Html5 Css Akta

Andrea Carter Education Details

  • University Of Wisconsin-Madison
    University Of Wisconsin-Madison
    Biochemistry
  • University Of Wisconsin-Milwaukee
    University Of Wisconsin-Milwaukee
    And Scientific Writing

Frequently Asked Questions about Andrea Carter

What company does Andrea Carter work for?

Andrea Carter works for Regeneron

What is Andrea Carter's role at the current company?

Andrea Carter's current role is Technical Writing Consultant.

What is Andrea Carter's email address?

Andrea Carter's email address is an****@****tes.com

What schools did Andrea Carter attend?

Andrea Carter attended University Of Wisconsin-Madison, University Of Wisconsin-Milwaukee.

What are some of Andrea Carter's interests?

Andrea Carter has interest in Social Services, Cooking, Volunteering, Economic Empowerment, Environment, Education, Long Distance Running, Hiking, Science And Technology, Animal Welfare.

What skills is Andrea Carter known for?

Andrea Carter has skills like Molecular Biology, Technical Documentation, Technical Writing, Validation, Change Control, Gmp, Fda, Pcr, Biotechnology, Sds Page, Gel Electrophoresis, Life Sciences.

Who are Andrea Carter's colleagues?

Andrea Carter's colleagues are Djordjo Zotovic, Kate Gilleece, Enrico Maria Zingone, Jennifer Davis, Chloe Kim, Dara Kirke, Kirstin Vonborstel.

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