Quality Assurance Systems

Jiranny Paulino

Plainfield, NJ. *****

Cell: 908-***-****

Email:********@*******.***

SKILLS:

Master control, VeevaVault, Blue Mountain Regulatory Asset Management, LIMS, Training module, SAP, Quality Systems, APR, TRACK-WISE, BOX, SHARE DRIVE, ONE DRIVE MICROSOFT TEAMS, POWER POINT, MINITAB, AUDITS. PHARMA, BIOTECH AND RADIOPHARM QUALITY RISK MANAGEMENT,FDA, ICH GUIDELINES, 21CFR, QUALIY ASSURANCE, REGULATORY AFFAIRS and compliance, graphs and pivot tables EXPERIENCE

GE HealthCare October-2022- present

Quality Engineer III/Quality Manager/ Global Quality & Regulatory

• provides quality systems support for a PeT pharmaceutical manufacturing facility

• Direct day to day responsibility of quality assurance activities at the facility.

• work with the Quality Assurance management to ensure compliance with applicable cGMP/QSR/ISO requirements

• Participate in routine QA functions (e.g., change controls, document review and approval, vendor approval and validation reviews

• Release Pet drug product,

• Collect and present metrics to management;

• Provide QA oversight for manufacturing/engineering and QC records.

• review QC reports charts, graphs

• Validation records

• Provide oversight from CMO batch production records

• Data transfer from batch records to APR

• Review deviation and investigations

• Batch disposition

• Product release

• Final inspection

• Work closely with the product complain team to determine what actions to take to address the problem

• Assist with the annual quality product review

• Analyze production process

• Review investigation, deviation and approved change control

• Work closely with distribution to ensure the products meet all the requirements before going out the door following the EU regulations

• Analyze quality risks to help prevent them

• Manage a team of four QAs, time approval, trainings, annual performances etc

• Assist with the labeling process to ensure labels meet costumer requirements

• Support external and internal audits

Kashiv BIOSCIENCES January 2021-October 2022

Quality Specialist II- April 2022-October 2022

Quality Specialist I – March 2022-April2022

• Support manufacturing with the issuance and revision of batch records

• Perform water sampling

• Ensure everybody receive the appropriate training before issuing a batch record

• Do the meeting minutes agenda for the VP of Quality

• Help with the harmonization of SOPs for the two sites

• Perform line clearance for manufacturing activities

• Support with costumer complain and investigation

• Managed a QA team with 8 direct reports, including QMS specialists,doc control and QA associates

• SME person for internal and external audits.

Quality Assurance Associate

• Provide QA support during manufacturing operation

• Assist all departments in the generation of quality system documentation such as SOPs, deviation, investigation report equipment/ system qualification, protocol, reports, and change control

• Perform Annual GMP and GDP trainings

• Train new employees

• Assist in document control activities such as training records entries, logbooks, and notebooks issuance, archival etc.

• Quality release of raw material and finished products

• Interview new candidates

• Review Calibration and maintenance in Blue Mountain

• Helped to implement our Quality Systems

• Provide technical support to the Veeva users

• Perform other functions as required or assigned

• QA oversight and support of clinical studies

• Provide QA oversight and guidance for the development and implementation of SOP

• Support GCP audits

• Review non-conformances in blue mountain

• Work directly with QC for clinical operations

• Support the hiring process of new QA talents

• Keep track of all the clinical supplies

QUVA PHARMA December 2019-January 2021

Quality Systems Specialist

• Interact with various departments of the company to address required updates on procedures, forms, and batch records

• Ensure that all documents always have the most current and up to date versions

• Assist with audits

• Assist in new employee training programs

• Give technical support to master control users

Amneal Pharmaceuticals October 2017-December 2019

Sr. Document Control Specialist

• Maintained employee training records

• Managed the Analytical Research and Development (ARD) department’s documentation

• Assisted with file migrations

• Kept track of all incoming and outgoing documents, folders, and logbooks

• Issued lab incident report numbers and review closed incident reports before filing them accordingly

• Ensured the proper calibration of all lab instruments

• Maintained a log of controlled substance usage

• Ensured that all reference standards comply with the Drug Enforcement Administration (DEA) requirements

• Support CM team with ANDA submissions

• Regulatory documents

• BLA/NDAs,

• Managed a team of four document specialists

Endo Pharma October 2016-August 2017

Quality Technician II (Contract)

• Applied current good manufacturing practice (cGMP) principles by following standard operating procedures (SOP’s)

• Recorded incubator temperature daily

• Assisted the DEA with audits of controlled substances LabCorp ) August 2016-October 2016

Temporary Lab Assistant

• Prepared samples and specimens

• Produced accurate and reliable data by interpreting results

• Maintained a clean work area

East Brunswick Municipal Court June 2016-August 2016 Temporary Violations Clerk (Temp)

• Maintained accurate records and filing

• Answered phone calls and walk-in inquiries regarding court related matters Aurolife Pharma December 2015-June 2016

Manufacturing Tech (Contract)

• Ensure quality production

• Package capsules in accordance with SOP’s and cGMP’s

• Assist DEA by inventorying drugs

Aspire Pharmaceuticals March 2013-December 2015

Manufacturing Tech (Contract)

• Inspect and package capsules in accordance with SOP’s and cGMP instructions

• Package nutraceutical products to be shipped to various vendors Roche Molecular Systems 2007-2012

Quality support for manufacturing (Contract)

• Remove kits from the line for inspection and ensure the proper vials are inside

• Visible inspection of medical kits

• Ensure batch records are complete and contain proper documentation as per GMP and GDP

• Other duties as assigned

EDUCATION

2021-2024

Stayer University, Master of Business Administration (MBA) and IT security management 2016-2020

Stayer University, Bachelor of Science-Criminal Justice with a concentration in homeland security and emergency management

2008-2015

Union County Community College, Cranford, NJ. Associate of Science-criminal justice with a minor in biology

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