Pamela Reyes Mangual
Arecibo,Puerto Rico
Summary
Obtain a position to use my professional skill sets and keep growing. A position where my knowledge could be used to exceed the company goals. Willing to learn, to succeed in fast paced environment, complete all assigned tasks and responsibilities. And be part of a team that contributes towards the growth and the betterment of a company.
Overview
7
7
years of professional experience
Work History
Quality Analyst
AbbVie Biotechnology, LTD
Barceloneta, Puerto Rico
10.2022 - Current
- Monitor performance through appropriate Key Performance Indicators (KPIs) for CAPA’s, Change Plans and Change Control
- Ensure a timely completion of actions identified in: Exception Reporting System, Change Management or Risk Management quality records and programs
- Facilitate meetings to ensure timely identification and management of events, including but not limited to triage and CAPA reviews
- Hands on in the on boarding process of new laboratory personnel
- Interviewed potential participants to determine eligibility
- Assisted in the different audit readiness teams by providing requested documentation in a timely manner
- Monitored implementation of corrective actions in response to audit recommendations
- Hands on knowledge on One Vault system to generate and process documents change controls of laboratory procedures, specifications, stability program policies and validation protocols
- Active communication skills with VRB members explaining the changes and following up until the approval of the documents
- Provided support to the technical operation departments with modifications and approval of validation documents
- Participated in the test method transfer activities for Risankizumab 55 mg/0.37 mL (pediatric dose) and Risankizumab 180 mg/mL and Risankizumab 360mg/mL
- From supporting strategy development, validation documentation writes up and test method documents updates.
Laboratory Technician II Process Development (Temporary Drive Program)
AbbVie Biotechnology, LTD
Barceloneta, Puerto Rico
04.2021 - Current
- Authorship for Tech reports and validation reports
- Document creation, document changes and reviews
- Support the process validation (data collection and verification) and tech transfer initiatives for CMC3.150 at ABL
- Support in data collection and verification for regulatory filing of Risankizumab CMC2.150.HIC process
- Participated in data collection and verification for pending actions/document revisions for audit readiness for the Risankizumab CMC2.150 process
- Provide training for validation data collection and verification (including PI, Empower, MES and POMS systems) to other lab members
- Support on seventeen validation protocols for CMC2.Non-HIC and CMC2.HIC process, in data collection, document optimization and verification
- Provided filling support, worked with the recompilation of data and data verification for the Risankizumab filling
- Worked with the response for the FDA and data optimization for the CPV runs new parameters
- Generate and analyze precise, reliable, and reproducible data in a timely manner, under the direction of a more scientific leader
- Follow established experimental protocols and assess results
- Recognized and report experimental variances
- Technical proficiency in multiple techniques and appropriately modify protocols, as required, to suit the changing needs of research or development sciences
- Provide Lab-based process support, improvement, and investigations
- Provide in-process product quality mapping data during campaign (i.e., A280, SOLO VPE) & quality attribute harmonization metrics
- Support the team to perform lab-based studies focused on process innovation, capability development and continuous lab and plant improvement initiatives.
Laboratory Technician II Quality Control Laboratory
AbbVie Biotechnology, LTD
Barceloneta, Puerto Rico
06.2018 - 04.2021
- Performed procedures to quality control including SDS Page, ELISA, DNA & Poros HPLC
- Hands on knowledge in systems such as LIMS, Empower, Atlas, NuGenesis, Citrix, Trackwise, PI Vision, SAP, POMS and MES
- Demonstrated the ability to perform change control requests
- Participate in projects such as validation of equipment for data integrity and Test Method transfer for new incoming products
- Generation and verification of stabilities reports for bulk drug substance and drug product to comply with regulatory requirements and regional specifications
- Validation process for samples of new product Risankizumab 150mg/mL
- In process testing data verification
- Reconcile data authorization
- Certificate trainer in testing such as ELISA, UV, SDS Page and appearance of Adalimumab.
Laboratory Technician I
Abbvie Biotechnology, LTD
Barceloneta, Puerto Rico
12.2016 - 06.2018
- Maintained documentation and control procedures
- Hands on knowledge in LIMS and EMPOWER systems
- Performed “5S” audits and internal audits in the laboratory, recognizing areas of improvement making sure the laboratory is in compliance
- Performed laboratories procedures in accordance to policies and protocols
- Assist on the filling of quality control training data
- Responsible for the storage and retrieval of frozen samples as required
- Performed procedures to quality control including pH testing, solution preparation, pipetting, centrifugation, conductivity, densitometry, UV assay, aseptic techniques, cell counting and appearance of Adalimumab
- Followed the EPA and OSHA mandates to ensure the proper safe disposal of hazardous samples and waste
- Handle samples and materials throughout their stability life sequence this includes performing samples pulling, organization and discarding sample according to applicate procedures
- Assist in the preparation of all required documentation for sample shipments to outside laboratories.
Education
Bachelor’s degree of Science - Microbiology
University of Puerto Rico, Arecibo Campus
05.2015
Skills
- Leadership
- Data Reviewing
- SOP Development
- Protocol Review
- Audit processes
- Quality Improvement
- Risk Assessment
- Quality processes
- Statistical analysis
- Quality assurance
- Laboratory equipment calibration
- Analytical concepts
- Microsoft Office
- Analytical testing
- Operational Excellence
- Training employees
- Attention to Detail
Accomplishments
- AbbVie Excellence Award: Make Possibilities Real for FDA Response Support. Recognition for pulling process parameters and online PI data, strategizing responses to satisfy FDA request and mitigate potential constraints to ABL process.
- AbbVie Excellence Award: Agile & Accountable for Timely Data Review. Timely support in getting required data verified for the Risankizumab CMC2.150 filing.
- Completed the Research on the Pyrodinium bahamense as a final requirement for the Science Degree in Environmental Microbiology of the Integration Seminar Course at the University of Puerto Rico.
- Speaker at the 2013 Symposium An approach to Cancer Genetic and Epigenetics at the University of Puerto Rico.
- Research on the comparison of DNA extracted from fresh meat and canned chicken using a modified protocol with sodium chloride in the University of Puerto Rico, Arecibo campus.
- Research on the tolerance of heavy metals lead and nickel silver in bacteria associated with marine Najas Guadalupensis.
Attributes Capabilities
- Accurate, reliable, diligent and focused on the timely, quality completion of all lab procedures.
- Work well under pressure and time constraints within high-volume environments.
- Teamwork oriented
- Proficient speaker and writer in both languages English and Spanish
- High level of integrity and trustworthiness values
Timeline
Quality Analyst
AbbVie Biotechnology, LTD
10.2022 - Current
Laboratory Technician II Process Development (Temporary Drive Program)
AbbVie Biotechnology, LTD
04.2021 - Current
Laboratory Technician II Quality Control Laboratory
AbbVie Biotechnology, LTD
06.2018 - 04.2021
Laboratory Technician I
Abbvie Biotechnology, LTD
12.2016 - 06.2018
Bachelor’s degree of Science - Microbiology
University of Puerto Rico, Arecibo Campus
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