Ingrid Rodriguez
Las Piedras
Summary
Chemist with over 20 years of experience working in biotechnology, medical device, and pharmaceutical industry. Dedicated 15 years to technical roles (quality control and manufacturing area) with solid background in QC lab analysis and operations, NPI process/analytical method transfer/validations, and related documentation. During the last five (5) years, have managed learning and developmental responsibilities and programs supporting the people’s learning needs and the business needs, as well. Throughout all these years, have developed interpersonal/communication skills to the point that motivated others through company cultural changes and continuous improvement initiatives. Bringing enthusiastic and emotional intelligent leadership applying negotiation skills to achieve goals within established timeframe and in compliance. Among strengths, can list, critical/analytical thinking, the ability to work in cross-functional teams with a great sense of urgency and passion.
Overview
20
20
years of professional experience
1
1
Certification
Work History
SR. ASSOCIATE TRAINING & DEVELOPMENT
Amgen Manufacturing Limited
11.2022 - 11.2023
- Facilitated New Hire Orientations.
- Certified as ATD Instructional Designer
- Certified as Six Boxes Performance Thinking Practitioner to conduct Human Performance Analysis and support right kind of behaviors that support good performance.
- Supported training evaluations such as Training Impact Assessments (TIA), Review for Obsolescence and Change Control impact assessments.
- Supported Investigations by participating in Human Performance assessments.
- Performed data evaluation to identify trends in Human Performance categorized deviations.
- Participated in Error Management forum
- Activity coordination to support academies (QA Academy and FLM Academy)
- Created content to enhance current training materials (FLM Academy) to address client’s learning needs.
- Generated and approved training requests in OTRT, as required.
- Co-led Human Performance Governance forum
- Conducted Human Performance assessments to support Deviation process, New Product Introductions and performance issues in operational areas.
- Utilized customer feedback to improve product offerings.
- Trained and supported new team members, maintaining culture of collaboration.
- Created solutions for customers to satisfy specific needs, quality and budget.
SR. SPECIALIST TECHNICAL AND ON THE JOB TRAINING
Bristol Myers Squibb
08.2022 - 11.2022
- See subsequent professional experience, since returned to this role after completing a special assignment period.
MANAGER, CHEMICAL LABORATORY
Bristol-Myers Squibb
03.2021 - 08.2022
- Defined priorities and created schedule for the testing of materials and/or products received in the laboratory (finished products, complaints and validation/special lots).
- Assured performance of laboratory tasks in compliance with company policies and regulations such as safety, GMP, personnel.
- Conducted cross-training activities to assure that lab analysts perform required tests and provide flexible support to the business.
- Designed adequate developmental plan for direct reports, considering their interests and strengths.
- Facilitated daily tier meeting with finished product lab analysts to discuss test schedules, lab metrics (RFT, Cycle time adherence, training adherence, etc.) and track/solve issues that may impact productivity, delivery, quality, or people using problem-solving tools.
- Assured that testing of materials are performed following established standard testing procedures to ensure quality and accurate release of materials.
- Assured that personnel have available all the necessary equipment, instruments, and reagents in order to complete all specified tests.
- Assisted the QC Laboratories Associate Director in the preparation of capital and operating budgets, as well as in future manpower requirements (forecasting) for the laboratories.
- Evaluated performance metrics and monitored closely the RFT of the lab
- Initiated Triage meetings when deviations were identified, or OOS results were obtained.
- Supported Lab Quality Events.
- Prepared on time reports to measure and describe the laboratory performance.
- Participated in laboratory control systems performance evaluations and improvements (such as change control, equipment maintenance programs, budget control, procedures, and technical documentation).
- Participated in department’s goal setting and deployed its implementation through every lab analyst under my supervision
- Monitored chemical laboratories employees by shop-floor presence to assure procedural adherence, usage of RFT tools and provided feedback to employees, as needed.
- Evaluated opportunities to develop and implement initiatives to improve compliance, customer service and productivity of the chemistry laboratory.
- Led the EHS Committee of Administration Building (B7) to maintain a Safety culture
- Participated in Pest Control Taskforce meetings as Lab SME.
TECHNICAL AND ON THE JOB TRAINING SR. SPECIALIST
Bristol Myers Squibb
04.2018 - 03.2021
- .Administered the Site Qualification Training Program in terms of compliance with corporate policies.
- Led, coordinated, and provided new hire onboarding training to develop new resources with basic set of skills
- Developed trainers in the operational areas, including Warehouse, QC, Manufacturing, Engineering, Maintenance, and Materials Management, to coordinate training throughout the plant
- Designed regulatory training processes (GMP) needed at the plant
- Developed training evaluation tools
- Proficient in training content creation both for Instructor led and online delivery in PowerPoint (Presenter) and Articulate (Storyline 360).
- Conducted Change Control Impact Assessments as Training SME and generated child actions to implement controls, when required.
- This required direct communication with global compliance and training team located in New Brunswick site.
- Managed and controlled effective training records system.
- Identified and pursued opportunities to use technology to maximize and facilitate knowledge transfer (webcams installed in conf rooms for virtual training
- Monitored effectiveness of knowledge transfer programs and make necessary corrections.
- Performed Root Cause Analysis (RCA) to determine the causal factor(s) that contributed to Human Error Category Quality Events (QE) and recommends appropriate corrective and preventive actions (CAPA)
- Conducted Human Error risk prevention evaluations to identify gaps and areas of improvement to assure processes are robust and with appropriate controls to avoid human errors.
- Provided guidance for the creation and review of qualification skill modules.
- Reviewed Work Instruction and SOP for alignment and harmonization with the validated process.
- Evaluated and updated staff “Learning Plans” for qualifications tasks to ensure a systematic approach and compliance.
- Reviewed and Approved documents Electronic Documentation Management System.
- Recorded documented training activities in Electronic Learning Management System (ELMS).
- Generated ELMS reports to monitor training adherence of employees
- Coordinated and delivered technical and regulatory trainings.
- Worked with the site areas to update training requirements, specifically Quality department.
- Participated as KM SME during Pest Control Charter project and developed training material to increase awareness and improve people’s behaviors
- Led a project for the incorporation of Analytical Methods and Testing Standards into ELMS.
BIOCHEMIST I
BD Biosciences
11.2010 - 04.2018
- Led and established the strategy for purification method transfer (as receiving site) of new products (monoclonal antibodies).
- Created new batch records based on the documents provided from the transfer site and local procedures.
- Revised SOP's, batch records and forms.
- Performed purification of monoclonal antibodies (CTX, ANX, HIC) including chromatographic column packing, equilibration and cleaning.
- Performed formulation of purified and/or conjugated antibodies.
- Conducted and documented FMEA exercises to mitigate risk and ensure high quality standards in various manufacturing processes (buffer prep, purification and formulation).
- Initiate deviations (Trackwise) and supported root cause identification and consequently, the corrective and preventing actions.
- Performed in-process analysis such as IEF, SDS-PAGE and HPLC.
- Volunteered as Mentor in Quality Mentorship program with PEPFAR Labs4Life to perform baseline assessment and implement controls in Hawassa Hospital at Ethiopia, as required by WHO regulations (ISO 15189).
- Evaluated production activities and provided suggestions for quality improvements and cost control.
BIOANALYTICAL LABORATORY ANALYST
Bristol Myers Squibb
03.2008 - 11.2010
- Initiated analytical incident reports and conducted investigations.
- Designed, validated, and implemented an analytical method to verify the effectiveness of a cleaning process.
- Performed laboratory analysis (SDS-PAGE, IEF, ELISA, Protein Concentration, HPLC, etc.) to biological products, documented and interpreted the results.
- Reviewed and approved the anayltical results of others.
- Participated in new product method transfers (Erbitux, Orencia) and interpreted results.
- Proactively, created new SOPs and revised existing ones
- Also, new forms were created to robust the laboratory documentation and reconciliation process.
- Laboratory Process Owner for the Cetuximab cycle time reduction Kaizen project.
- Participated during Russian and Korean regulatory audits as SME during lab walkthroughs.
- Performed SDS-PAGE analysis in front of Russian auditors and received excellent outcome.
- Led the implementation and sustainability of 5S in the Bioanalytical lab.
- Provided Classroom and On-the-job trainings.
QAL SR. ASSOCIATE
Amgen Manufacturing Limited
08.2006 - 10.2007
- Reviewed/approved analytical test results and solution preparations in accordance with methods and specifications
- Performed HPLC analysis for protein samples for Epogen, Neupogen and Neulasta (In-process or Final) through several techniques, such as, size exclusion, ionic exchange, and reverse phase
- Also analyzed cleaning samples through HPLC using Evaporative Light scattering Detector (ELSD)
- Performed SDS-PAGE analysis for proteins utilizing several techniques, such as, Western Blot, Coomassie Stain and Silver Stain
- Enhanced and revised forms used to document analysis.
LABORATORY ANALYST
Temporary Positions In QC Labs: Aerotek, Kelly Scientific
06.2003 - 08.2006
- Cleaning validation methods optimization in BMS for different Active Product Ingredients (API).
- Conducted experiments to change the different variables of each method and determine the best parameters to improve the product recovery.
- Supported Bulk area performing in-process laboratory analysis.
- Performed laboratory tests for solid dosage forms such as Identification through FTIR, Dissolution and Content uniformity and Impurities determination through HPLC, Thin Layer Chromatography (TLC).
Education
BS INDUSTRIAL CHEMISTRY -
UPR
Humacao, PR06.2005
CERT. INDUSTRIAL BIOTECHNOLOGY -
UPR
Humacao, PR12.2007
Skills
- Strong Critical Thinking & Analytical
- Proficient in Technical writing
- Analytical Method Transfer/validation for NPI
- Team Leadership
- Project Coordination
- Schedule Development/Management
- Problem-Solving & Decision-Making
- Proficient in MS Office (Word, Excel, PPT), Smartsheet, CDOCS, Trackwise, SAP, Empower, LIMS
- Data Analysis & Reporting
- Training and Development
Certification
- HUMAN ERRORS REDUCTION CERTIFICATION, Business Excellence Consulting, Inc., 10/2020
- ATD INSTRUCTIONAL DESIGN CERTIFICATE, Association for Talent Development, Inc., 04/2023
- SIX BOXES PRACTITIONER CERTIFICATE, SIX BOXES PERFORMANCE THINKING, Inc., 06/2023
Timeline
SR. ASSOCIATE TRAINING & DEVELOPMENT
Amgen Manufacturing Limited
11.2022 - 11.2023
SR. SPECIALIST TECHNICAL AND ON THE JOB TRAINING
Bristol Myers Squibb
08.2022 - 11.2022
MANAGER, CHEMICAL LABORATORY
Bristol-Myers Squibb
03.2021 - 08.2022
TECHNICAL AND ON THE JOB TRAINING SR. SPECIALIST
Bristol Myers Squibb
04.2018 - 03.2021
BIOCHEMIST I
BD Biosciences
11.2010 - 04.2018
BIOANALYTICAL LABORATORY ANALYST
Bristol Myers Squibb
03.2008 - 11.2010
QAL SR. ASSOCIATE
Amgen Manufacturing Limited
08.2006 - 10.2007
LABORATORY ANALYST
Temporary Positions In QC Labs: Aerotek, Kelly Scientific
06.2003 - 08.2006
BS INDUSTRIAL CHEMISTRY -
UPR
CERT. INDUSTRIAL BIOTECHNOLOGY -
UPR
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