WILNELIA CARMONA RIVERA
Naguabo,PR
Overview
4
4
years of professional experience
1
1
Certification
Work History
Sr. Associate Manufacturing (Document Control)
Kelly Services (Amgen Manufacturing Limited, Ltd.)
08.2022 - Current
- Checking and editing documents for accuracy and compliance.
- Ensuring the secure destruction and disposal of sensitive documents.
- Maintaining the security of confidential documents.
- Adhering to regulatory requirements.
- Working with colleagues to ensure consistency of documentation practice across the company.
- Ensuring documentation integrity.
- Proofreading documents upon request.
- Ensures controlled documents conform with applicable procedures and are maintained to latest revisions.
- Responsible for timely distribution of draft and final controlled documents.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Data Specialist
Droguería Betances
02.2021 - 08.2022
- Responsible for validating and adjusting the integrity and accuracy of the data within the system, ensuring compliance with defined specifications.
- Performance of data accuracy checks and validations to identify discrepancies and apply appropriate corrections.
- Evaluating process and methodologies in data recording to ensure agility and effectiveness.
- Attendance at professional improvement workshops, seminars, or conferences, as per recommendation and/or referral.
- Preparation of periodic reports and briefings as per request or previous establishment.
- Compliance with personnel manual, as well as any other guidelines that may be established either verbally or in writing.
- Responsible for creating and editing SOPs pertaining to te QA area.
- Maintenance of internal/client databases to ensure their integrity and availability.
- Responsible for documenting the process to be followed within the management of data registration, ensuring its uniformity and consistency.
- Responsible for communicating any recommended adjustments or modifications for their approval.
- Participation within meetings, assigned work committees and/or professional activities.
- Performing clerical tasks as assigned, such as filling, collating, or photocopying documents, among others.
- Collaboration in various areas or departments upon request.
- Performing tasks or functions related to business level processes.
Supplier Quality Specialist
ISO Group (Medtronic)
11.2019 - 05.2020
- Responsible for maintaining a supplier database and including performance evaluations and quality control audits within it for internal access by company management and manufacturing personnel.
- Interpretation of engineering drawings.
- Responsible for researching and sourcing the best suppliers for the provision of necessary materials.
- Performing MRB assessments and specialized non-conformance dispositions on incoming materials.
Document Control Coordinator
Kelly Services (Janssen Ortho, LLC)
02.2018 - 08.2018
- Production batch closing activities within SAP.
- Responsible for auditing and assisting in making necessary GMP corrections for manufacturing batches.
- Maintenance within the SAP register and submitting of sampling forms to the quality department.
- Printing of controlled forms for batch production within the production area.
- Requesting reports of controlled forms for batch reconciliation.
Data Coordinator
Kelly Services (Pall Life Sciences Puerto Rico)
08.2016 - 11.2016
- Responsible for ensuring that all official Pall Life Sciences, LL documentation is created, reviewed and distributed to ensure accuracy, completeness and adherence to policies, procedures, and regulations.
- Performing monthly checks of drafting reports, recommendations and letters.
- Responsible for processing documents and providing information on regulations, procedures, and programs.
- Client Services.
- Performing visual and dimensional inspection according to specifications following QSRs and written procedures.
- Responsible for providing control of the documentation review process.
- Maintenance of ISO 900:2008 certification documentation requirements for BioPharma and Industrial business units.
- Responsible for typing and using computer, fax, copier and scanner.
- Responsible for typing 65 words per minute on the keyboard.
- Procedure folder audits, compilation and reporting of results.
- Responsible for reporting any non-conformances related to QC inspection and testing methodologies.
- Daily assistance to internal and external customers.
Quality Control Technician
Warner Chilcott Pharmaceuticals
02.2013 - 11.2013
- Control of the RBMs and COAs parameters and results database.
- Support on the development of processes and procedures.
- Responsible for creating and editing SOPs pertaining to the QA area.
- Preparation of special and ad hoc reports, summaries or responses to queries.
- In charge of deciding on the standards to be achieved.
Education
Associate Degree - Pharmacy Technology
Universidad Del Turabo
Gurabo, P.R. 06.2018
Master's Degree - Criminal Justice
Universidad Del Turabo
Gurabo, P.R.01.2017
Bacherlo's Degree - Business Administration
Universidad Del Turabo
Gurabo, P.R. 06.2014
Skills
- Ability to use basic laboratory techniques
- Excellent interpersonal relationship management skills
- Logical and scientific reasoning
- Adaptability and liking to change
- Excellent oral and written communication skills
- Able to lead work teams
- Knowledge in the use of Microsoft Office
- Software, mainly Word, Excel, and PowerPoint,
- As well as knowledge in the use of Diamond, CPS, NSLDS, SAP and ASW400 software
Affiliations
Pharmacy Technician, prepared to work within the area of prescriptions or pharmacy in search of wellness and
improvement of quality of life. Willing to be part of a multidisciplinary team and participate in disease prevention
plans. In addition, Specialist with experience in the field of Sales and Customer Service. Oriented to offer the best
services, products, and solutions according to the unique needs of each client, generating trust in the company
and the services provided.
Languages
Spanish
Native or Bilingual
English
Limited Working
Certification
- Quality Inspector Certification Program for FDA Regulated Industries.
- AQL Sampling Procedures for Inspection by Attributes-ANSI/ASQ Rev 2008 Standard
- How to Effectively Write Standard Operating Procedures (SOP's) for FDA Regulated Industries
- FDA Quality Investigation and CAPA Certification Program
- Good Documentation Practices for FDA Compliance
- Introduction to Good Manufacturing Practices, Pharmaceutical Industries (21CFR Part 210/211
Timeline
Sr. Associate Manufacturing (Document Control)
Kelly Services (Amgen Manufacturing Limited, Ltd.)
08.2022 - Current
Data Specialist
Droguería Betances
02.2021 - 08.2022
Supplier Quality Specialist
ISO Group (Medtronic)
11.2019 - 05.2020
Document Control Coordinator
Kelly Services (Janssen Ortho, LLC)
02.2018 - 08.2018
Data Coordinator
Kelly Services (Pall Life Sciences Puerto Rico)
08.2016 - 11.2016
Quality Control Technician
Warner Chilcott Pharmaceuticals
02.2013 - 11.2013
Associate Degree - Pharmacy Technology
Universidad Del Turabo
Master's Degree - Criminal Justice
Universidad Del Turabo
Bacherlo's Degree - Business Administration
Universidad Del Turabo
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