Jaqueline A. Gomez
Rockford,Illinois
Summary
Reliable Clinical Quality Distribution Supervisor bringing 5 years of Quality experience in the Clinical department. Eager to apply past experience in performing visual/destructive inspections per specified instructions, data collecting/entry, and exceptional time management in the Laboratory as a Pharmaceutical Scientist l
Overview
9
9
years of professional experience
Work History
Clinical Quality Supervisor
PCI PHARMA SERVICES
Rockford, IL
10.2021 - Current
- Manages and assigns the daily tasks of inspectors in the Clinical Label Room, Distribution and Receiving Quality at logistics in order to maintain continuity
- Coaches, mentors and develops the Clinical Quality Label Room, Distribution and Receiving Inspectors
- Collaborates with Clinical Warehouse leadership to ensure that sales orders are shipped out in a timely manner
- Troubleshoots any issues that might come up in label room, receiving and distribution area
- Collects data to initiate Master Control Events or NONCs
- Dispositions EVENTs or NONCs by verifying that the assigned actions have been completed and verifying supportive documents
- Updates process procedures as needed
- Currently overseeing the monthly monitoring of temperatures and have Identified areas of improvement in the temperature excursion response process
- Took part of Kaizen event to improve on time releases and successfully continues to apply improvement ideas with the IQA team at logistics that has drastically brought down the number of open receipts and has improved on time releases
Clinical Quality Lead
PCI Pharma Services
Rockford, IL
04.2019 - 10.2021
- Continuously oversees workload of sales orders to ensure their ontime departure
- Addressees and resolves quality issues regarding sales orders
- Performs inspection and sign-off of piece piece ensuring completeness against batch record requirements and blinding of study when applicable
- Provides support to quality inspectors and other coworkers within the Clinical department to accomplish goals and address issues related to our products and processes.
- Creates and completes HOLD tickets at any point issues have been deemed a quality concern
- Assesses when a Non-conforming material situation exists, creates report, segregates material and eventually dispositions the NMR
- Implemented the use of email notifications for retains which allowed a faster batch record review and an a more accurate verification of cold chain return times
- Implemented a standard way of properly communicating distribution issues with a bigger audience ensuring that no one was left out of important information
- Created NMR locations at both plants which benefits different departments across Clinicals
Clinical Quality Inspector I & II
PCI Pharma Services
Rockford, IL
01.2017 - 03.2019
- Effectively performed and documented visual and/or destructive inspections during production per batch record requirements
- Gathered retains at different stages of production per instructions as well as sample requests outside of work orders
- Performed quality walk offs after major/minor cleans of production areas
- Conducted quality checks of outgoing sales order shipments
- Verified material on destruction reports to ensure their destruction
- Assisted quality leads in the processing of retains, batch record review, and audits
- Took part of new customer launches as well as new inspection requirements such as VeriPac and FTIR
- Assisted Quality receiving in the review of quality receiving reports
Clinical Packer Technician
PCI Pharma Services
Rockford, IL
12.2015 - 12.2016
- Packaged clinical trial medication according to batch record instructions
- Took part of OPEX to reduce lot in/out times effectively
- Performed inspections of returned medication in the Returns department
- Assisted distribution warehouse in the pack-out of sales order shipments
- Trained in material staging and issuance
Education
High School Diploma -
Thomas jefferson High School
2015
Skills
- Collaborative
- Analytical
- Adaptable
- Strategic thinker
- Detail oriented
- Self-motivated
Timeline
Clinical Quality Supervisor
PCI PHARMA SERVICES
10.2021 - Current
Clinical Quality Lead
PCI Pharma Services
04.2019 - 10.2021
Clinical Quality Inspector I & II
PCI Pharma Services
01.2017 - 03.2019
Clinical Packer Technician
PCI Pharma Services
12.2015 - 12.2016
High School Diploma -
Thomas jefferson High School