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Andrea Carter personal email
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."
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RegeneronAustin, Tx, Us -
Consultant - Iops Facilities & ItRegeneron Oct 2023 - PresentTarrytown, New York, Us -
Quality And Compliance ConsultantPropharma Oct 2023 - PresentRaleigh, North Carolina, Us -
Clinical/Ivd Technical WriterThermo Fisher Scientific Jul 2021 - Jul 2023Waltham, Ma, UsCreated 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. -
Technical Documentation SpecialistMolecular Templates Mar 2020 - Jul 2021Austin, Texas, UsCreated 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. -
Quality Assurance SpecialistMolecular Templates Feb 2019 - Mar 2020Austin, Texas, UsManaged 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. -
Quality Assurance EngineerPerkinelmer, Inc. Sep 2017 - Dec 2018Shelton, Ct, UsDiagnostics (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. -
Scientist IiiThermo Fisher Scientific Aug 2015 - Sep 2017Waltham, Ma, UsManufactured 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 -
Technical WriterThermo Fisher Scientific Feb 2012 - Feb 2015Waltham, Ma, UsEdited 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. -
Scientist IiiLife Technologies (Formerly Ambion, Inc) May 2006 - Feb 2012Waltham, Ma, UsFormulated 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. -
Senior Research TechnicianUniversity Of Chicago Hospitals May 2005 - May 2006Chicago, Il, UsDeveloped 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. -
Associate ScientistAbbott Feb 1999 - May 2005Abbott Park, Illinois, UsCharacterized 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. -
Operations Specialist IAbbott Jun 1996 - Feb 1999Abbott Park, Illinois, UsFormulated 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
Andrea Carter Education Details
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University Of Wisconsin-MadisonBiochemistry -
University Of Wisconsin-MilwaukeeAnd 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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