Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
LANGUAGES
Timeline
SUMMARY OF QUALIFICATIONS
Generic

CAROLYN RIVERA

Millersville

Summary

Results-driven professional with over 18 years of experience in the pharmaceutical industry, specializing in process development, quality assurance, and manufacturing within biotechnology and cGMP environments. Proven expertise in implementing Six Sigma and Lean methodologies to enhance operational efficiency and drive continuous improvement. Skilled in managing multiple priorities in complex, fast-paced settings while delivering exceptional results. Committed to fostering collaboration and innovation to meet organizational goals and exceed expectations.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Quality Reviewer

Catalent Pharma Solutions
09.2024 - 04.2025
  • Determine deviation investigations to ensure completeness, accuracy, and compliance including but not limited to test methods, Process Control (IPC) reports, Standard Operating Procedures (SOPs), and Manufacturing Batch Record (MBRs).
  • Provide technical guidance to investigators to promote business record content and quality.
  • Help investigators improve their technical writing skills and Root Cause Analysis by following ALCOA+ principles.
  • Support investigators in addressing client comments for final approval and ensure batch release on time.
  • Work flexibly and committed to ensure monthly quality metrics are achieved.
  • Maintain strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
  • Reduce turnaround time for reviews by effectively prioritizing tasks and managing deadlines.

Sr. Investigator

Catalent Pharma Solutions
01.2024 - 08.2024
  • Direct support to manufacturing Cell and Gene Therapy to support the completion of backlog deviations, quality metrics, and on-time batch release within the Trackwise system.
  • Leads or author investigations including root cause analysis and assesses product impact using input from various departments.
  • Conduct direct contact with internal customers across the site and external customers to support the investigations.
  • Use the escalation process to re-assess initial deviation classification as necessary.
  • Conduct data gathering, trending, and data presentation as needed to support investigations including but not limited to completing an initial event report.
  • Technical knowledge to ensure process understanding is adequate to investigate deviations.
  • Document issues clearly identified during the investigation utilizing strong technical writing skills.
  • Perform Root Cause Analysis and Investigation in Trackwise.
  • Assess Quality impact after thoroughly investigating each deviation.

Sr. Deviation Writer

Catalent Pharma Solutions
04.2022 - 12.2023
  • Direct support to manufacturing Drug Product Formulation/Filling to support the completion of backlog deviations, quality metrics, and on-time batch release within the Trackwise system.
  • Author investigations including root cause analysis and assesses product impact using input from various departments.
  • Conduct interviews with internal customers to support the investigations.
  • Conduct initial assessment, data gathering, and data presentation to Deviation Review Board and CAPA team.
  • Technical knowledge to ensure process understanding is adequate to investigate deviations.
  • Document issues clearly identified during the investigation utilizing strong technical writing skills.
  • Determine Root Cause Analysis and Final Impact Assessment in Trackwise.
  • Assess Quality impact after thoroughly investigating each deviation.

Associate

Amgen Manufacturing Limited
01.2013 - 10.2021
  • Author, review, and/or data verification for protocol and technical reports.
  • Initiate, review, revise, and approve of technical procedure guidelines, SOP templates, and forms along with execution practices and comply with regulatory requirements.
  • Perform independent experiments depending on support materials, qualification/re-qualification, process improvement initiatives, and normal operations.
  • Participate in manufacturing investigations and CAPA resolutions.
  • Collaborate in Design of Experiment (DOE) on plan laboratory studies.
  • Responsible for laboratory metric internal events investigations and CAPA proposals.
  • Support internal quality oversight audits at the laboratories.
  • Plan experimental laboratory schedule for culture seed expansion and production stages.
  • Manipulate and maintain samples in monoculture culture in bioreactor (2L-20L) for both mammalian and microbial cells applying aseptic techniques.
  • Interpreted laboratory results to provide technical advice to scientists.
  • Address non-routine events by applying lean tools.
  • Analyze results and communicate management and functional groups.
  • Responsible for departmental safety metrics on a monthly basis.
  • Support and implementation of Environmental Health and Safety (EHS) initiatives.
  • Streamlined operational efficiency by identifying areas for improvement and proposing actionable solutions.
  • Effectively managed multiple competing priorities while maintaining focus on delivering exceptional results for clients and the organization.
  • Perform Product Annual Review Cycle analysis.

Laboratory Technician

Amgen Manufacturing Limited
02.2006 - 08.2012
  • Laboratory Subject Matter Expert (SME) providing technical guidance to new hires.
  • Laboratory SME with knowledge in 100+ solutions, media, and buffer preparation to support all biochemistry, microbiology, upstream, downstream, and fill/finish to support Quality Control (QC), Process Development (PD), and manufacturing daily operations.
  • Coordinate daily and weekly laboratory tasks/activities to ensure task completion to support QC and PD operations.
  • Performed risk assessment through FMEA analysis to evaluate all media, solutions, and buffers.
  • Performed routine cleaning, sanitizing, calibrating, and/or verification of equipment/instruments.
  • Perform laboratory equipment troubleshooting.
  • Operated basic laboratory equipment such as balances, pH meters, spectrophotometers, autoclaves, laminar flow hoods, pipettes, and blood gas analyzer.
  • Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
  • Documented information by maintaining daily logs and equipment record books.
  • Calibrated and maintained instruments to keep equipment fully operational.
  • Kept laboratory supplies prepared by inventorying stock, placing orders and verifying receipt.
  • Participated in continuous improvement initiatives, contributing to the ongoing optimization of laboratory operations.
  • Prepared reagents, media and solutions to use for laboratory testing and analysis.
  • Participate in internal audits readiness to ensure regulatory compliance.
  • Performed equipment/instrument impact assessment associated with Out of Specification (OOS) events.
  • Generate work orders to replace/repair equipment/instrument in OOS status.
  • Collaborated with Work Order Administration (WOA) to route in progress work orders.
  • Ensure raw material supply to support QC and PD operations.
  • Ensure compliance with company procedures and regulatory standards.
  • Ensure that all laboratory equipment meet the specified calibrations on a daily basis.

Education

Master - Business, Quality Management

Bachelor - Science, Biology, Microbiology concentration

Skills

  • Six Sigma and Lean Tools (Root Cause Analysis, 5S, Fishbone, 5 Why's etc)
  • Technical Writing
  • Editing and review
  • Dependability and cooperation
  • Problem Solving
  • Aseptic Techniques
  • Equipment Troubleshooting
  • Microsoft Office (Word, Excel, PowerPoint)
  • Critical thinking
  • Continues Improvement
  • Attention to detail

Accomplishments

  • Excellence in Operations Award for serving patients (ensures supply).
  • Excellence in Operation Award for implementing sustainable environmental practices (cost reduction and recycling goals exceeded).

Certification

  • Six Sigma Green Belt (SSGB)
  • Six Sigma Yellow Belt (SSYB)
  • Industrial Biotechnology Techniques

LANGUAGES

Spanish
English

Timeline

Quality Reviewer

Catalent Pharma Solutions
09.2024 - 04.2025

Sr. Investigator

Catalent Pharma Solutions
01.2024 - 08.2024

Sr. Deviation Writer

Catalent Pharma Solutions
04.2022 - 12.2023

Associate

Amgen Manufacturing Limited
01.2013 - 10.2021

Laboratory Technician

Amgen Manufacturing Limited
02.2006 - 08.2012

Bachelor - Science, Biology, Microbiology concentration

Master - Business, Quality Management

SUMMARY OF QUALIFICATIONS

  • 18+ years of experience in cGMP Regulatory environment and compliance.
  • 1-year leader for Process Development laboratory startup.
  • 1-year operational excellence leader with 8+ years of experience in lean tools.
  • 1-year safety leader with 25+ safety improvement projects implemented.

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CAROLYN RIVERA