, , 100 Montgomery St. 10th Floor(555) 432-1000, resumesample@example.com
Summary
Detail-oriented, self-motivated, reliable professional with the ability to take ownership of all responsibilities. with
dedication with Good manufacturing practices, quality Assurance and control, seeking an opportunity to become part
of a dynamic team by performing accurately and complying with all protocol and standards.
Skills
Good Manufacturing Practices (cGMP)
MS Word, Excel, and PowerPoint
Adobe acrobat Sign
Quality assurance procedures
Equipment knowledge and handling
Attention to detail
Regulatory compliance
Data Entry
Team Player
PCR knowledge
Quick learning skills
MLPA Test method,DNA Microarray Technology
Good Aseptic techniques
Regulatory Affairs
Documentations
Experience
02/2022 to CurrentQuality Assurance SpecialistBae Systems | Hanscom Air Force Base, MA,
Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
Manage and support the Change control(DCN) process and activities throughout the approval and release process.
Administer the documents control function to ensure all controlled documents are approved and implemented according to procedure.
Maintain the change control program to capture changes with equipment,processes or methods.
Manage equipment calibration program and any associated SOPs.
Maintain supplier files and current approved suppliers list.
participate in quality audits.
Perform acceptance activities to ensure products meets specifications.
Maintain employees training files,review and audit employee training files as needed
Develop and conduct GMP and QMS employee training as needed.
Maintain equipment calibration,inspection,maintenance procedure(s) to ensure that the system(s) are compliant.
Review Device History Records(DHR)and data forms for completeness and accuracy.
10/2019 to 02/2022Clinical Laboratory Scientist IISutter Health | San Carlos, CA,
Perform pre-analytical and post-analytical testing, Revise and Adhere to Standard Operating Procedures (SOPs).
Adhere to FDA regulations that governs the facility with current good manufacturing practice (cGMP).
Able to design,analyze and interpret controlled experiments to facilitate assay development
Thorough knowledge of and experience in general molecular biology techniques with aseptic and general microbiology.
Managing and maintaining calibration records as well as coordinating calibrations. Maintain equipment logs and inventory
Prepare Work Orders,review work order for accuracy and completion
Coordinate Manufacturing needs with Quality Control
Cooperate with coworkers within an organized team environment and work with minimal supervision
Effectively communicate project status to supervisor peer and other staff
Manage time effectively to complete assignments in the expected time frame. Perform work assignments accurately timely and safely
Maintained physical lab equipment, detecting malfunctions and troubleshooting to ensure optimum service.
11/2018 to 05/2019Biopharmaceutical Manufacturing AssociateEurofins Scient. | Mebane, NC,
Downstream Process: Operate and Maintain Chromatography Equipment and Purification Filtration Systems,
Complete and Review batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate.
Using technical expertise to remove parts from automated systems for sanitization.
Responsible for taking samples to ensure product integrity
Adhere to FDA regulations that governs the facility with current good manufacturing practice (cGMP)
Adhere to Standard Operating Procedures (SOPs)
03/2016 to 07/2018Microarray TechnologistJohns Hopkins Bayview Medical Center | Baltimore, MD,
Specimens processing for analysis and establish proper chronological priorities for Genetic testing
Performing Multiplex Ligation dependent Probe assay by manual and Robotic setups .(Hamilton Microstars, ABI 3500 and 3730 Genetic analyzers
Properly calibrate and troubleshoot equipment to ensure precise test results
Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
Adhere to quality control policies including equipment maintenance, reagent preparation and testing, and general lab practices
Facilitate research into genetic causes of disease
Monitor test performance and document corrective actions
11/2013 to 02/2016Tele-InterpreterAon Hewitt | City, STATE,
Delivered real-time, accurate oral translations and interpretations for clients.
Follow ethical codes that protect the confidentiality of information (HIPAA)
Compile terminology and information to be used in translations, including technical terms such as those for legal and medical material.
Translate messages consecutively into specified languages, maintaining message content, context, and style.
Refer to materials, such as lexicons, and computerized terminology banks, as needed to ensure translation accuracy.
05/2009 to 09/2013Pharmacy TechnicianTotal Care Pharmacy | City, STATE,
Establish or maintain patient profiles, including lists of medications taken by individual patients
Receive written prescription or refill requests and verify that information is complete and accurate.
Answer telephones, responding to questions or requests Price
File prescriptions that have been filled
Call Doctors office to get new refills for diabetic patient.
Education and Training
Expected in 2016Bachelor of Science | Biomedical ScienceInteramerican University of Puerto Rico, San Juan, PRGPA:
Expected in 2018Master of Science | Regulatory scienceJohns Hopkins University, Baltimore, MarylandGPA:
Regulatory Affairs Online Program
Emphasis in the regulatory approval processes for global and domestic biotech products
Coursework in regulatory science, current good manufacturing, laboratory and clinical practices, as well as product development and manufacturing of products GPA: 3.6
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