Amanda Hernandez Email and Phone Number
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Amanda Hernandez personal email
Skilled biopharmaceutical professional with broad capabilities in the biopharmaceutical upstream and downstream manufacturing industry including leading various client NPIs/ tech transfers, performing and monitoring critical processes, aseptic technique, SME for deviations and CAPAs, and strong leadership in a GMP environment. Also have experience in Quality Assurance and Document Control. Considered a motivated self-starter, analytical thinker, skilled multi-tasker, who is detail-oriented with a demonstrated ability to lead others along with lead projects, and effectively collaborate as a leader. My goal is to leverage my current skillset in order to provide value to an organization that values hard work and dedication to improve the lives of others.
Agc Biologics
View- Website:
- agcbio.com
- Employees:
- 1203
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Manufacturing Projects SupervisorAgc Biologics Apr 2024 - PresentBoulder, Colorado, United States
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Sr Associate ScientistBiogen May 2023 - Apr 2024Transfer new products into the SSM/LSM facilities for clinical and PPQ campaigns; support commercial programs; SME assessments for deviations; review/approve PARs and BPRs; Data trending; authoring various technical protocol and reports; technical improvement projects and continuous improvement ideas. -
Associate Scientist IiiBiogen Apr 2022 - May 2023Cary, North Carolina, United States
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Process EngineerJust - Evotec Biologics Jul 2020 - Apr 2022Seattle, Washington, United StatesDrafted and revised controlled documents (Batch Records, Operating Procedures, Operational Qualification Documents, and Raw Material Specifications); Assisted in quality records like non-conformances or CAPAs; Performed and monitored critical processes (flask passages, Single Use Bioreactor operations) in aseptic clean room environments (ISO5, ISO7, ISO8, and ISO9); Conducted and lead validation projects on incubators, freezers, and autoclaves; Onboarded various types of equipment (IQ, PQ, and OQ); Created qualification documents to accompany the onboarded equipment, and executed the qualification procedures for the equipment; Lead our Upstream Manufacturing team with NPI and wrote batch records; Trained to create master and working cell banks and selected to be a lead cell banking engineer; Assisted in Root Cause Analysis for deviations and non-conformances; In addition, this position required teamwork and communication cross-functionally to have success. -
Aseptic Filling Production SupervisorAlcon Oct 2019 - Jul 2020Fort WorthPlanned, organized, supervised, and directed the daily activities and schedules of associates who were engaged in the production of pharmaceuticals and managed projects and process improvements within respective areas, all while maintaining regulatory compliance; Created new documentation processes to streamline daily activities and help clarify sanitizations; Created meaningful relationships with reporting staff and implemented goals for development gaps within the team; Conducted interviews, hired staff, and organized training to ensure success; Qualified to aseptically gown in sterile fill rooms and train staff how to aseptically gown. -
Quality Assurance AnalystAlcon Mar 2019 - Oct 2019Dallas/Fort Worth AreaQuality Analyst on Shop Floor of ASPEX, employed by Tech Observer. Primary quality presence during manufacturing; Performed audits, logbook reviews, non-conformity/deviation initial investigations; performed product impact/scope analyses, and ensured appropriate corrections were performed prior to resuming production per defined procedures; Operated within general established guidelines while still making risk-based decisions for unexpected issues; Reviewed production MBR’s for release.
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Emergency Veterinary TechnicianI-20 Animal Hospital Apr 2018 - Apr 2019
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Certified Allergy SpecialistUnited Allergy Services Aug 2017 - Mar 2018Colleyville, Tx -
Document Control AssociateAmgen May 2014 - Aug 2014Longmont, Colorado, United States
Amanda Hernandez Education Details
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Biology/Biological Sciences, General
Frequently Asked Questions about Amanda Hernandez
What company does Amanda Hernandez work for?
Amanda Hernandez works for Agc Biologics
What is Amanda Hernandez's role at the current company?
Amanda Hernandez's current role is MFG Projects Supervisor | Cross-Functional Leader | Excels in Problem Solving and Teamwork | Product Quality and Patient Safety Focused.
What is Amanda Hernandez's email address?
Amanda Hernandez's email address is am****@****con.com
What schools did Amanda Hernandez attend?
Amanda Hernandez attended University Of Northern Colorado.
Who are Amanda Hernandez's colleagues?
Amanda Hernandez's colleagues are Sonja Lizet Dalgaard, Henry Martinez, Cpsm, Nickolai Alban, Kyle Taylor, Maria Tranberg Jaszczak Børresen, Wulan Nurlelasari, Jennie Nolfi.
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