Brandi Norden
Operations Specialist at SCA Pharma- Claim this Profile
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English Native or bilingual proficiency
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Spanish Limited working proficiency
Topline Score
Bio
Credentials
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Adult First Aid/CPR/AED
American Red CrossSep, 2019- Nov, 2024 -
TIPs
Tips AlcoholOct, 2017- Nov, 2024
Experience
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SCA Pharma
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Operations Specialist
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Oct 2021 - Present
Quality event investigator for the operations department. Focusing on detail-oriented investigations, timely event closure, event trending, and FDA readiness. Perform GDP reviews, interviews, training, aseptic behavior correction, and other tasks as necessary to support compounding operations.Edit Operations SOPs for accuracy and compliance.
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Cleanroom Process Lead
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Mar 2020 - Oct 2021
Acting floor supervisor overseeing the compounding of controlled and non-controlled IV drugs in a 503B facility. Reassign work orders to improve daily efficiency. Correct aseptic behaviors, GMPs, and GDPs of sterile drug compounders. Manage employee attendance and performance. Collect and analyze compounding data for process improvement. In-process and final GDP review of GMP records. Assist with quality investigations including deviations, OOLs, OOTs, and other quality events. Manage consumable inventory for compounding.
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Cambrex
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Cleanroom Services Analyst I/II
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Dec 2017 - Mar 2020
Perform enumeration and morphological assessments on agar plates for viable CRS sampling. Communicate with clients regarding data and reports via email and phone. Work closely with Account Management, Quality Assurance, Sample Login, and management to resolve client issues. Schedule and provide training to new employees. GDP review of technical data. Subject Matter Expert for equipment maintained in Blue Mountain for the CRS department. Assist with the completion of quality documents including non-conformances and CAPAs. Write, review, and improve standard operating procedures and work instructions.Trend internal monitoring data using Excel. Assist with courier scheduling. Schedule shipping of client materials. Able to use Labvantage LIMS, MasterControl, and Blue Mountain software effectively. Assist with FDA inspections as necessary. Courier for pickup/drop-off of client samples as needed. Able to perform multiple tasks as assigned by management with excellent time management, communication, and problem-solving abilities. Work as a team member and leader to meet departmental goals, including maintaining cGMPs, GLPs, and FDA readiness.
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Berkshire Sterile Manufacturing
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Quality Control Microbiologist
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Jan 2017 - Oct 2017
Performed routine environmental monitoring of Grade D-A Cleanroom. EM including viable surface plating, viable and particulate air sampling, enumeration of viable plates, RODI and WFI sampling, and data trending using Excel. Performed QC microbiology testing on collected water and raw, in-process and finished drug products including endotoxin, bioburden , TOC, and conductivity. Assisted with the implementation of spectroscopic endotoxin reader. Practiced cGMPs, GLPs, GDPs, and aspetic technique. Performed line clear/start for manufacturing and QC inspection of finished products. Wrote and reviewed quality documents including SOPs, deviations, and excursions. Acted as the QC Microbiology Subject Matter Expert during critical audits. Performed other tasks as assigned both independently and as a team with good communication and time management.
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Pace Analytical
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United States
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Environmental Services
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100 - 200 Employee
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GC-ECD Prepatory Technician
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Mar 2016 - Dec 2016
Prepare high volume of extracts from soil, water, air and other matrices for Gas Chromatography (GC) analysis using various cleanup methods for PCBs, pesticides, and herbicides. Update sample and standard data using Element LIMS program. Startup and perform basic maintenance on GC instruments. Analyze standards and samples for accuracy, precision, and contamination using ChemStation software. Perform all tasks and duties independently and in a timely manner.
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Extractions Technician
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May 2015 - Mar 2016
Extract PCBs, EPTHs, PAHs, Semi-volatiles, and other compounds from soil, paint, caulking, other solids, and water using a variety of extraction techniques. Methods include soxhlets (3540C), microwaving (3546), and manual solvent extractions. Responsible for sample preparation and uses general laboratory methods, techniques, equipment, and instrumentation in compliance with Con-Test's Quality Assurance programs and SOPs, to support laboratory operations through general maintenance of laboratory and supply storage areas, equipment, instruments and supplies.
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Western New England University
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United States
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Higher Education
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700 & Above Employee
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Laboratory Assistant
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Aug 2012 - May 2015
I assisted Physics and Chemistry professors with the set-up and clean-up of the laboratories each week. I assisted students with proper protocol techniques and ensure laboratory safety. In the past, I have analyzed student samples using H-NMR and IR spectroscopy for characterization in the Organic Chemistry lab. I have also graded laboratory activities in the Biology lab. I assisted Physics and Chemistry professors with the set-up and clean-up of the laboratories each week. I assisted students with proper protocol techniques and ensure laboratory safety. In the past, I have analyzed student samples using H-NMR and IR spectroscopy for characterization in the Organic Chemistry lab. I have also graded laboratory activities in the Biology lab.
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Life Supply Corporation
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1 - 100 Employee
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Summer Intern
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Jun 2014 - Aug 2014
My main objective for the summer was to create an account for LifeSupply in the website Big Contacts. This involved contacting nursing homes, retrieving their updated contact information, troubleshooting the program, and setting it up to be highly user-friendly for the employees there. I also established a comprehensive list of new nursing homes and corporate affiliates to be serviced by this medical supply company. I assisted in acquiring and organizing files that had been misplaced during the company's movement to a new location. I continued to perform daily tasks in Brightree including patient entry, inventory transfer, equipment rentals, supply purchases, and purchase requests.
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Life Supply Corporation
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1 - 100 Employee
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Summer Intern
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Jun 2013 - Aug 2013
My main goal for the summer was to convert the company's medical supply ordering/rental system software from Pacware to Brightree. This included extensive patient and inventory transfers, new patient entry, troubleshooting the software, and employee training of the Brightree software. Also performed inventory management, data organization, filing, and purchase requests. My main goal for the summer was to convert the company's medical supply ordering/rental system software from Pacware to Brightree. This included extensive patient and inventory transfers, new patient entry, troubleshooting the software, and employee training of the Brightree software. Also performed inventory management, data organization, filing, and purchase requests.
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Caregiver
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Sep 2009 - Aug 2013
I took care of an elderly woman, sometimes for up to 2 weeks. I would clean her house, prepare all her meals, do her laundry, play games with her, and help her get ready for bed. I also cared for 5-7 dogs, 2 cats, many fish, and an African Grey Parrot. I took care of an elderly woman, sometimes for up to 2 weeks. I would clean her house, prepare all her meals, do her laundry, play games with her, and help her get ready for bed. I also cared for 5-7 dogs, 2 cats, many fish, and an African Grey Parrot.
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Education
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2011 - 2015
Western New England University
Bachelor's Degree, Biology/Biological Sciences, General -
2007 - 2011
Stoneham High School
High School
Community
