Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic
Fitri Soeratinoyo

Fitri Soeratinoyo

1117 Village Drive, Avenel,NJ

Summary

Detail-oriented QC Associate with proven skills in quality compliance, safety management, and efficient multitasking. Committed to maintaining clean environments and adhering to SOPs for optimal production outcomes.

Overview

17
17
years of professional experience

Work History

QC/Production Associate II

SOFIE
Somerset, NJ
06.2023 - Current

Production Technician:

  • Operated Radiopharmaceutical automated synthesis: Performed FDG, NaF, PyL, FBB production runs using radiosynthesizer units such as GEFastLab, Synthera, Trasis, and Synthera+, adhering stricly to SOPs.
  • Perform material acceptance according to SOPs to ensure all materials/reagents are accepted according to SOPs and within expiry.
  • Ensure all equipment is appropriately qualified prior to use
  • Ensure completion of applicable cGMP documentation.
  • Perform basic computer-controlled cyclotron operations for FDG, NaF, PyL, and FBB production under the advisement of site Cyclotron and Facility Engineer.
  • Maintain a clean and safe working environment.
  • Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.
  • Maintain all qualification and validation requirements for entering ISO classified area : Gowning validation and Materials Transfer validation.
  • Perform Enviromental Monitoring of classified areas according to SOPs to routinely monitor the air quality and microbial contaminations level present in the room.
  • Clean classified and non-classified areas according to SOPs.
  • Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to: Investigations, Corrective and Preventative Actions, Deviations, Out of Specifications, No or Atypical Yields, Manufacturing Records, Logbooks, Attend internal meetings as required.
  • Aseptic Technique.
  • Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
  • Trained new associates on equipment operation and safety protocols, fostering a safe enviroment.

Quality Control (Chemist):

  • Operate QC equipment to test finished products, ensuring compliance with established standards : HPLC, GC.
  • Perform FDG, NaF, PyL, and FBB quality control (QC) processes according to SOPs.
  • Assist with basic maintenance of QC equipment.
  • Ensure all equipment is appropriately calibrated and qualified prior to use.
  • Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
  • Maintain detailed documentation in compliance with Good Documentation Practices (GDP).
  • Perform Gas Chromatography based on GC Injection Technique.
  • Perform Pipette Technique.
  • Perform Radiochemical Identity, Radiochemical Purity, and Chemical Purity of 18F by High-Performance Liquid Chromatography (HPLC) included solutions preparations.
  • Perform Thin-Layer Chromatograpy (TLC).
  • Perform PH Testing of Final Drug Product.
  • Perform Radionuclidic Identity of 18F by Half-Life Determination.
  • Perform Radionuclidic ID of 18F by Gamma Spectroscopy.
  • Perform Bacterial endotoxins test using Endosafe® nexgen-PTS™ units.
  • Perform limit test for the Cryptand 222 (Kryptofix) content in Final Drug Products (FDP) using the iodine method.

Production Clerk

NuWorld Beauty
Carteret, NJ
03.2020 - 07.2021
  • Prints labels with correct item, lot, and expiration dates.
  • Prepares code blocks with correct lot and expiration dates.
  • Gathers required components for each work order and places in a controlled labe cage.
  • Receives, stores and issues labels.
  • Uses barcode printers to print code labels for cases and pallets.

Quality Control Inspector

NuWorld Beauty
Carteret, NJ
10.2017 - 06.2018
  • Conducted visual and functional inspections to ensure product quality standards.
  • Identified and documented defects, initiating corrective actions as needed.
  • Collaborated with production teams to resolve quality issues promptly.
  • Maintained accurate records of inspection results and non-conformities.
  • Responsible for inspecting pallets that have been repaired to make sure they meet customer specifications.
  • Responsible for inspecting Finished Good's pallets before picking up by the forklift.
  • Perform other duties as assigned.
  • Inspect pallets in a safe and secure manner at a rate that meets company standards.
  • Inspection of Labels goods and components.
  • Inspection product day code if it is correct after prodoctions.
  • Assign status approved, hold or reject to Finished Good's pallet.

Customer Service

Bank Rakyat Indonesia, Tbk
Indonesia
04.2009 - 06.2016
  • Provided exceptional customer support to resolve inquiries and enhance client satisfaction.
  • Maintained friendly and professional customer interactions.
  • Assisted customers with banking needs and inquiries.
  • Educated customers on online banking and mobile banking applications.
  • Assisted clients with account management, including transactions and loan inquiries.
  • Educated customers on banking products and services to increase engagement.
  • Managed complex customer complaints, ensuring timely resolution and follow-up.
  • Collaborated with team members to streamline service processes and improve efficiency.
  • Trained new staff on customer service protocols and best practices for issue resolution.
  • Analyzed customer feedback to identify trends and recommend process improvements.
  • Collaborated with team members to achieve branch sales targets consistently.
  • Streamlined banking processes for improved efficiency and reduced wait times.
  • Assisted customers with loan applications, enabling them to make informed financial decisions.
  • Oversaw account maintenance tasks such as updating personal information or ordering checks for clients, ensuring smooth operations within the branch setting.
  • Identified potential fraudulent activities, protecting bank assets and customer accounts from loss.
  • Educated customers on available products and services, promoting cross-selling opportunities for the bank.
  • Provided exceptional customer service by addressing inquiries and concerns in a timely manner.
  • Developed strong relationships with clients through personalized attention and expert financial advice.
  • Handled various accounting transactions.
  • Referred customers to other banking departments for specialized services.
  • Cross-sold credit cards, loans and other bank products.
  • Monitored and verified suspicious activity on customer accounts.
  • Trained new hires on customer service policies and procedures.
  • Processed applications for new accounts.
  • Performed account maintenance by closing out accounts and changing customer addresses.
  • Generated monthly reports on customer activity and customer feedback.

Education

Bachelor of Economics - Accouting Management

Samratulangi University
Indonesia
09-2008

High School Diploma -

Manado Vacational High School
Indonesia
06-2003

Skills

  • Efficient multitasking
  • Packaging and labeling
  • Production support
  • Computer skills
  • Product inspection
  • Product assembly
  • Quality control
  • Machine operation
  • Materials handling
  • Workflow optimization
  • Manufacturing
  • Equipment operation
  • Safety management
  • Materials management
  • Mechanical troubleshooting
  • Assembly and production
  • Manufacturing processes
  • Production scheduling
  • Quality and compliance
  • Quality inspections
  • Product packing
  • Assembly procedures
  • Product packaging
  • Hazardous material handling
  • Equipment troubleshooting
  • Equipment calibration
  • Documentation
  • Cross-training
  • Batch production
  • GMP compliance
  • Teamwork and communication
  • Positive attitude
  • Following instructions
  • Good communication
  • Safe machine operation

Languages

English
Limited Working
Indonesian
Full Professional

Timeline

QC/Production Associate II

SOFIE
06.2023 - Current

Production Clerk

NuWorld Beauty
03.2020 - 07.2021

Quality Control Inspector

NuWorld Beauty
10.2017 - 06.2018

Customer Service

Bank Rakyat Indonesia, Tbk
04.2009 - 06.2016

Bachelor of Economics - Accouting Management

Samratulangi University

High School Diploma -

Manado Vacational High School
Fitri Soeratinoyo