Summary
Overview
Work History
Education
Skills
Work Availability
Work Preference
Languages
Timeline
87
Jannette Torres

Jannette Torres

Quality and Compliance Consultant
Caguas

Summary

Strategic QA/QC Consultant with 30+ years of experience across pharmaceutical and environmental industries. Recognized for deep expertise in Quality Systems, Data Integrity, Manufacturing Compliance, and Regulatory Inspections. Proven track record in leading complex remediation initiatives, managing cross-functional investigations, and elevating QA/QC team performance. Combines technical precision with business agility to resolve compliance challenges and drive continuous improvement in dynamic, fast-paced environments.

Overview

30
30
years of professional experience

Work History

Senior Quality Systems Consultant

5WsGxpertise (Legacy 5Ws Consulting)
12.2022 - Current
  • Monitored key project activities and timelines using digital tools to keep deliverables on track and well-documented.
  • Coordinated team check-ins and updates to address issues promptly and maintain project momentum through cross-functional collaboration.
  • Conducted comprehensive batch record reviews (lab and manufacturing), ensuring completeness, accuracy, and full compliance with GMP/SOPs/FDA/EMA standards.
  • Lead and oversee deviation investigations and root cause analysis, applying deep technical expertise to identify systemic issues and implement CAPAs.
  • Conducted GMP compliance audits of third-party CMOs, assessing quality system performance, documenting findings, and supporting regulatory inspection readiness.
  • Performed QC and QA lab record reviews, including OOS/OOT analysis, stability and analytical documentation, validating data integrity and regulatory adherence.
  • Managed quality system processes: change control, CAPA, non-conformance reports (NCR), product complaints and complaint investigations.
  • Adapted rapidly to evolving business needs and project demands, demonstrating high flexibility in priorities across multiple clients and time zones.
  • Served as senior technical lead, applying expert-level problem-solving to resolve non-compliance issues and mentor client-quality teams.
  • Supported internal audits, regulatory inspections, and prepare responses to FDA/EMA observations, ensuring inspection-readiness and robust documentation.

Senior QA Consultant Training

ALKU LLC, CMO Client
06.2022 - 08.2022
  • Designed and performed a 2-day classroom GMP training for four contract manufacturing facilities (CMO) Based on the new revision of the FDA Guidance for Industry, Investigating Out-of-Specification Results for Pharmaceutical Production, May 2022. The training addressed several FDA observations issued to the Client as a result of the last regulatory inspection of CMO facilities. The training documentation was submitted as evidence of completion as part of the response to the Warning Letter.
  • The training guided the participants through the entire investigational process, from the detection of an out-of-specification result, through writing a formal Phase I/ Phase II laboratory investigation. Root Cause analysis tools (Ishikawa, Fault Tree Analysis, Is/Is Not, among others). The training addressed cross-departmental and full manufacturing deviations (Phase II manufacturing). In addition, the training also covered assessing and managing CAPA’s, Change Controls, Stability, Out of Trend results, and examples of recent cited FDA observations to GMP facilities.

Senior QA Consultant

Carlton National Resources, Biopharma (Plasmid) Client
01.2022 - 05.2022
  • Performed review of laboratory electronic records to determine data integrity non-compliances events in accordance with regulations and SOP procedures.
  • Performed manufacturing batch record (MBR) review for final disposition.
  • Identified manufacturing/QC laboratory issues and make recommendations to initiate quality deviations.
  • Assessed and initiated deviations related to unplanned events as defined per site procedures.
  • Provided Quality Assurance signature approval on behalf of the client to close deviations, CAPAs, effectiveness checks, and validation reports.

QC & Quality Systems Remediation Senior Consultant

Quality Executive Partners (QxP), Client Mexico City (CDMX)
01.2020 - 08.2021
  • Provided quality oversight of QC laboratory operations (Raw Materials, Stab, and Finished Product) on quality issues such as OOS results, deviations, and non-conformances.
  • Assessed and identified areas of improvement, data integrity issues not adequately assessed by quality management.
  • Performed analytical batch record review, including chromatographic computerized acquisition software (Empower 3) for accuracy, completeness, and conformance to company quality standards as well as to cGMP’s and cGDP’s. Responsible for material disposition for manufacturing purposes.
  • Supported QC Laboratory activities by assessing, reviewing, and approving Standard Operating Procedures (SOPs), CSV Protocols and Reports, Analytical Test Method Validation Protocols and reports, Change Controls, CAPA’s, Laboratory OOS Reports, Deviation Reports, Component Specifications, Validation and Qualification of Laboratory equipment, among others.
  • Led investigation process, providing and facilitating consistent disciplined execution of all aspects related to investigations and ensured completeness and determination of most probable root causes.
  • Provided mentoring, guidance, and structured training to RM laboratory analysts in the execution of analytical testing based on the individual product monographs contained in pharmacopeial compendia (USP/NF, EP, JP, and Mexican Compendia)

Compliance Data Integrity Senior Consultant

Toscano Consulting Group, LLC- Akorn Pharmaceuticals
03.2019 - 08.2019
  • Exercised independent judgement, within procedures and regulations, to provide decisions and guidance regarding compliance issues.
  • Performed review of computerized laboratory software electronic records to determine data integrity non-compliances events per regulations and SOP procedures.
  • Reviewed lab equipment audit trails to identify data deletion, chromatographic software manipulation, trial injections, data omission, mathematical errors, etc.
  • Performed audit trail data integrity review of Laboratory Validation Records submitted as part of the product ANDA submission.
  • Identified Method Validation deficiencies in accordance to site SOPs, USP, and ICH Guidelines.
  • Determined the grade of severity of data integrity non-compliance issues and assigned a severity level based on the potential impact on the marketed product.

CGMP Quality Engineer

ADMA Biologics Inc. (formerly Biotest Pharmaceuticals)
11.2016 - 03.2019
  • Supported GMP/GLP activities by reviewing and approving Standard Operating Procedures (SOPs), CSV Protocols and Reports, Analytical Test Method Validation, Change Controls, CAPA’s, Laboratory OOS Reports, Deviation Reports, Component Specifications, Validation and Qualification of Laboratory equipment, Process Validation Protocols and Reports
  • Supported GMP/GLP activities by reviewing and approving Standard Operating Procedures (SOPs), CSV Protocols and Reports, Analytical Test Method Validation, Change Controls, CAPA’s, Laboratory OOS Reports, Deviation Reports, Component Specifications, Validation and Qualification of Laboratory equipment, Process Validation Protocols and Reports.
  • Exercised independent judgement, within procedures and regulations to provide decisions and guidance regarding compliance issues.
  • Provided leadership within the Quality Assurance Department. Remain objective and maintain high standards of ethics, honesty, and urgency required to meet the quality standards, objectives, and goals.
  • Organized and conducted quality-related intradepartmental meetings and discussions.
  • Authored deviations related to unplanned events as defined per site procedures.
  • Mentored analysts in root cause analysis tools and technical writing skills to improve laboratory deviation records and the generation of Validation protocols and reports.
  • Collaborated in data analysis and report creation on quality metrics and key performance indicators (KPI’s).

Senior Compliance Consultant/Site Decommissioning

Quality Systems and Compliance Inc. (QSC), Novartis Pharma Division
01.2015 - 04.2016
  • Monitored status and scheduling of calibration activities for all laboratory analytical instruments and performed the necessary arrangements to complete the calibration work.
  • Managed priorities of scheduling calibrations in conjunction with laboratory Team Leaders/Management based on site decommissioning project needs.
  • Performed investigations related to calibration non-conformances and unplanned events as defined per site procedures.
  • Ensured that GMP instrumentation that has previously been under the site calibration program be end-calibrated and retired from service following the established procedures.
  • Authored Laboratory Equipment Change Control to document the individual decommissioning activities.
  • Performed Final Periodic Review for computerized laboratory equipment.

Senior QA/QC Validation Consultant/Quality Systems Supply Chain

Business Excellence Consulting (BEC), Neolpharma
06.2014 - 01.2015
  • Reviewed and Approved Analytical data for Laboratory equipment qualification, Test Method Validation, Test Method Transfer, and OOS/OOT investigations.
  • Reviewed and Approved Process equipment, Manufacturing/Packaging Validation/Qualification Protocols and Reports (IQ, OQ, PQ).
  • Reviewed and approved product and/or process change control documentation and specifications.
  • Performed on time cross-functional investigations regarding Product Field Alert and provided recommendations for process improvements and avoidance of re-occurrences.
  • Led and supported CAPA investigations and related Corrective and Preventive actions.
  • Performed timely reviews of CAPAs for accuracy and acceptance, providing recommendations for CAPA improvements to resolve non-compliance issues, as well as monitoring and tracking CAPA implementation to closure.
  • Performed updates to Standard Operating Procedures for the Supply Chain division and worked with each channel to document best practices to drive operational improvement and financial benefits. Supported the development, implementation, and maintenance of Supplier Quality initiatives to assure product process robustness and regulatory compliance.

Senior QC Lead Investigator Remediation Consultant (In-Process/Raw Materials)

Propharma Group (PPG), Hospira
03.2013 - 04.2014
  • Initiated and conducted comprehensive QC Analytical Laboratory investigations to determine potential product impact, identified Root Cause, and implemented Corrective and Preventive Actions by established procedures and timelines. Effectively communicated to management the status of assigned investigations (Raw Materials/In-process/Stability)
  • Ensured that all exception documents were written according to Policies and Site procedures and complied with FDA GMP regulations for the Analytical Laboratory’s operations.
  • Monitored and ensured that action plans have been implemented to eliminate recurrence.
  • Mentored and Discussed Laboratory Investigations' outcomes and Root Cause with laboratory personnel to avoid recurrence.
  • Coached and mentored laboratory analysts regarding adequate laboratory practices, techniques, and troubleshooting to improve performance and minimize laboratory investigations due to personal errors.
  • Performed Tracking and Trending of Investigations to identify quality issues trends.
  • Audited, reviewed, and approved Laboratory Records documentation, Analytical Raw Data, including but not limited to, Chromatographic Acquisition Systems (Empower), Category C instruments (PC-controlled), Training Records, Calibration Records, Preventive Maintenance (PM) Records, Standard Operation Procedures, Testing Specifications, Validation documents, and the Technical Reports, as required.

Senior Compliance Consultant (Remediation)

Quality Systems and Compliance Inc. (QSC) Novartis Consumer Health
08.2011 - 10.2012
  • Performed analytical evaluations of current Analytical Test Methods Validations to determine whether they are adequate, robust, and sensitive to demonstrate and assure a high level of accuracy and reliability for the intended use.
  • Conducted evaluations of Analytical Validation Reports and verified their conformance to Industry Standards (ICH Guidelines, USP Pharmacopoeia, etc.)
  • Ensured robustness and well-written investigations. Provided Guidance and Counseling to Novartis Investigators for the adequacy of Laboratory Investigation Reports, as well as Manufacturing, Packaging, Materials, and Warehouse Areas, before the final approval. Provided Counseling and recommendations for the adequacy of Investigation Reports related to Critical Complaints.
  • Evaluated Root Cause and Corrective/Preventive actions (CAPA’s) for adequacy and effectiveness to eliminate and/or reduce the possibility and re-occurrence of similar events. Utilized investigations tools, skills, and statistical knowledge to perform statistical analysis to support non-conformance investigation reports.
  • Audited and reviewed analytical complex data. Provided professional recommendations, where needed, to improve laboratory performance and investigation reoccurrences.
  • Provided Mentoring and Guidance and assisted in Corrective Actions required to obtain GMP-compliant documentation for remediation work. Provided training on Lessons Learned as the result of the identification of areas of GMP improvement.

Senior QC Analytical Validation Remediation Consultant

Quality Systems and Compliance Inc. (QSC), CibaVision
02.2011 - 08.2011
  • Evaluated Analytical Test Methods Validation Reports to determine whether they remained in compliance with current validation guidelines ICH and USP for adequacy, robustness, and sensitivity, among others, to assure a high level of accuracy and reliability for the intended use.
  • Authored Method Validation Protocols for the Qualification of Resins and Non-Compendial Materials.
  • Developed and executed Analytical Test Method Validation for several Non-Compendial materials according to current validation guidelines (ICH/USP) guidelines and authored the corresponding Method Validation Reports according to the site’s documentation procedures and requirements.
  • Initiated, resolved, and addressed documentation regarding deviations to approved Method Qualification Protocols.

Senior Laboratory Scientist (Contract position)

Mylan Pharmaceuticals
09.2010 - 02.2011
  • Performed Analytical Testing in a cGMP environment for Qualitative and Quantitative determinations of extractables and leachables, drug elution in support of Product Development, in-process, Release, and Stability samples.
  • Supported improvement of Analytical Test Methods. Provided expert technical recommendations for the performance of Analytical Test Methods and Instrument/Equipment troubleshooting.
  • Performed Laboratory investigations. Highlighted analytical problems and provided support in finding solutions.

Senior Environmental Validation Chemist (Contract position)

AESI International Inc.
07.2009 - 01.2010
  • Performed Method Qualification for EPA Methods (8000 Series) such as but not limited to: PCB’s Pesticides, Herbicides, BTEX, Diesel Range, Gasoline Range and Oil Range by GC.
  • Performed Method Qualification for EPA Volatiles 8260B using GC/MS Spectroscopy.

QC Senior Supervisor (Stability and Technology Transfer Laboratories)

Wyeth Pharmaceutical
01.2005 - 01.2009
  • Managed all activities associated with the daily operations of the Quality Control (QC) Stability and Method Transfer Laboratories.
  • Conducted Laboratory Investigation Reports for OOS/OOT for QC Stability, Analytical, and Product Validation Laboratories and ensured compliance with the cGMPs and Regulatory Agencies' requirements.
  • Analyzed statistical data for the evaluation and scientific judgment recommendations of adequate Corrective/Preventive Actions (CAPAs) to prevent the recurrence of non-compliances.
  • Supported Product Release, Stability, and Method Transfer/Validation Programs.

Quality Control Laboratory Supervisor (Raw Materials and Packaging Components)

Mova Pharmaceutical
09.2003 - 12.2004
  • Coordinated/supervised, trained, and performed Analytical Testing to Raw Materials (Compendial and non-Compendial) following USP/EP/JP Pharmacopoeias and/or established Testing Methods
  • Prepared weekly project status reports for upper-level management.
  • Responsible of the daily operation of Raw Materials and Packaging Component Laboratory
  • Conducted Laboratory Investigation Reports. Ensured the release and availability of Bulk materials/Packaging Components for manufacturing activities.

Senior Laboratory Chemist (Stability and Finished Goods)

Pfizer (formerly Pharmacia and Monsanto Searle)
10.1995 - 09.2003
  • Performed routine and complex laboratory tests for Raw Materials, In-process, Finished Products, and Stability samples according to prescribed test methods.
  • Provided training in laboratory instrumentation, such as but not limited to HPLC, GC, UV spectrophotometer, KF titrators, FTIR, etc.
  • Analyzed data from analytical tests. Performed statistical calculations and solved minor problems.
  • Performed Laboratory and Complaints investigations reports.

Education

Master's degree - Project Management

OBS Business School / Universidad De Barcelona
Spain
12-2022

B.S. - Chemistry

University of Puerto Rico
Cayey, Puerto Rico
05-1995

Skills

  • Experience in instrument performance qualification
  • CAPA implementation expertise
  • Transfer of analytical methods
  • Annual Product Review Expert
  • Stability Program Assessments
  • Deviation/Investigation Reports
  • Supply Chain / Vendor’s Program
  • Regulatory Inspections/Supplier’s Audits
  • Third Party Contract Lab and Supplier’s Audits
  • Batch Record Review/Disposition
  • Data Integrity Audit Review
  • Laboratory Remediation Plans
  • Quality Systems performance metrics (KPI’s)
  • Risk Assessments / Process Improvements
  • Data Integrity Auditor
  • Inspection Readiness

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference

Work Type

Contract WorkFull Time

Work Location

RemoteHybrid

Languages

English
Bilingual or Proficient (C2)
Spanish
Bilingual or Proficient (C2)
Italian
Elementary (A2)

Timeline

Senior Quality Systems Consultant

5WsGxpertise (Legacy 5Ws Consulting)
12.2022 - Current

Senior QA Consultant Training

ALKU LLC, CMO Client
06.2022 - 08.2022

Senior QA Consultant

Carlton National Resources, Biopharma (Plasmid) Client
01.2022 - 05.2022

QC & Quality Systems Remediation Senior Consultant

Quality Executive Partners (QxP), Client Mexico City (CDMX)
01.2020 - 08.2021

Compliance Data Integrity Senior Consultant

Toscano Consulting Group, LLC- Akorn Pharmaceuticals
03.2019 - 08.2019

CGMP Quality Engineer

ADMA Biologics Inc. (formerly Biotest Pharmaceuticals)
11.2016 - 03.2019

Senior Compliance Consultant/Site Decommissioning

Quality Systems and Compliance Inc. (QSC), Novartis Pharma Division
01.2015 - 04.2016

Senior QA/QC Validation Consultant/Quality Systems Supply Chain

Business Excellence Consulting (BEC), Neolpharma
06.2014 - 01.2015

Senior QC Lead Investigator Remediation Consultant (In-Process/Raw Materials)

Propharma Group (PPG), Hospira
03.2013 - 04.2014

Senior Compliance Consultant (Remediation)

Quality Systems and Compliance Inc. (QSC) Novartis Consumer Health
08.2011 - 10.2012

Senior QC Analytical Validation Remediation Consultant

Quality Systems and Compliance Inc. (QSC), CibaVision
02.2011 - 08.2011

Senior Laboratory Scientist (Contract position)

Mylan Pharmaceuticals
09.2010 - 02.2011

Senior Environmental Validation Chemist (Contract position)

AESI International Inc.
07.2009 - 01.2010

QC Senior Supervisor (Stability and Technology Transfer Laboratories)

Wyeth Pharmaceutical
01.2005 - 01.2009

Quality Control Laboratory Supervisor (Raw Materials and Packaging Components)

Mova Pharmaceutical
09.2003 - 12.2004

Senior Laboratory Chemist (Stability and Finished Goods)

Pfizer (formerly Pharmacia and Monsanto Searle)
10.1995 - 09.2003

Master's degree - Project Management

OBS Business School / Universidad De Barcelona

B.S. - Chemistry

University of Puerto Rico

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Jannette TorresQuality and Compliance Consultant