Anne Gertrude Velazquez
Poway,California
Summary
Detail-oriented Quality Control Manager with 17 years of experience in CDMO industry ensuring the quality of lot release. Skilled in preparing comprehensive quality control reports, including Method validation/qualification protocols and reports, SOPs CoAs, and investigations including deviations, OOS, CAPA, CC and OOT. Committed to efficiently inspecting all products for safety and quality issues to enhance customer experience. Proficient in MasterControl, ACE, Microsoft office and time management abilities.
Overview
17
17
years of professional experience
Work History
Manager of Quality Control Operations
Ajinomoto Bio-Pharma Services
06.2022 - 06.2023
- Oversaw three different QC departments including QC logistics, QC Stability and Technical Writer Team.
- Presented KPIs for various teams to present in quality councils with upper management.
- Contract and tech transfer review for new and existing clients
- Ensured testing was appropriately charged to ensure revenue generation.
- Proficient in OOS investigations, Change Controls, Deviations CAPA. Eliminated all open and delinquent OOSs and CAPA
- Heavy involved in internal and external client communication
- Innovative – helped to generate creative solutions to client and FDA issues.
Manager of Quality Control Operations
Ajinomoto Bio-Pharma Services
04.2018 - 06.2022
- Responsible for up to 11 direct reports
- Oversees all Chemistry testing for release, stability, in-process
- Analytical transfer/qualification of test methods. Ensured compliance with product phase appropriate approach.
- Metric generation for OOS and Invalids
- Direct communication with internal and external client
- Annual Budget management
- QC project management. Coordination of various projects with Analytical Technologies, Quality Control and Project managers
Supervisor of Quality Control
Ajinomoto Bio-Pharma Services
04.2016 - 04.2018
- Certificate of Analysis Generation
- Responsible for 7 direct reports
- Authorizing Final Product Specifications
- Reviewing SOPs, Master Production Batch records for Clinical and Commercial Batch Records within QAD (QMS system)
- Assisted in implementation of LIMS from a paper based system
- Releasing of lots within QAD and LIMS
- Metrics generation.
- Supervised and directed quality control personnel through effective mentoring, coaching and work delegation.
Quality Control Group Lead
Ajinomoto Bio-Pharma Services
04.2015 - 04.2016
- Responsible for 7 direct reports
- Direct interaction with Clients both internal and external
- Conducts investigations for OOS and deviation reports.
Senior Quality Control Associate
Ajinomoto Bio-Pharma Services
04.2013 - 04.2015
- Responsible for review for Buffers, Biologic and non GMP master production records
- Equipment Validation of new instruments.
Quality Control Associate
Ajinomoto Bio-Pharma Services
01.2010 - 04.2013
- Writing and revising Standard Operating Procedure, Study Reports, Validation Protocols and Validation
- Conducts preventative maintenance of equipment.
Senior Quality Control Assistant
Ajinomoto Bio-Pharma Services
01.2008 - 01.2010
- Assist in Out of Specification (OOS) investigations
- Experience in working closely with clients to complete qualifications and assay development
- Experience in writing deviations.
Quality Control Assistant
Ajinomoto Bio-Pharma Services
02.2006 - 01.2008
- Supports several departments to coordinate in-process, routine, feasibility and qualification testing
- Completes documentation timely in a cGMP environment
- Responsible for completing routine testing of in-process, release and stability samples
- Sterile techniques
- Gowning for GMP production area.
Education
San Diego State University
Skills
- Experienced in working in a fast paced environment with strict deadlines
- Communicates effectively across different departmental groups and with clients
- Experienced in technical matters related to computational and experimental methods for performing qualitative and quantitative data analysis
- Broad experience in conducting and performing release testing, and processing raw data for analysis in a cGMP environment for qualification, transfers and release testing for CoA generation
- Method Transfer and Method qualification
- Proficient in Investigations, CAPA, Deviations, OOS
- Analytical test methods performed: HPLC, CE-SDS, Endotoxin, Bioburden, Concentration, SDS-PAGE, Agarose Gel, Western Blot, Viscosity, CCIT, compendial methods
Others
Dedicated work ethic, Detail-oriented, Reliable, diligence, and aptitude., Work effectively within a team as well as independently with minimal supervision., Able to multitask in a busy work environment., Advanced skills in Microsoft Word, and Excel, Knowledge of LIMS system, Knowledge of Master Control system/ ACE (electronic documents), Knowledge of QAD, Knowledge of BM RAM, Experience with regulatory agency audits, Available upon request
Timeline
Manager of Quality Control Operations
Ajinomoto Bio-Pharma Services
06.2022 - 06.2023
Manager of Quality Control Operations
Ajinomoto Bio-Pharma Services
04.2018 - 06.2022
Supervisor of Quality Control
Ajinomoto Bio-Pharma Services
04.2016 - 04.2018
Quality Control Group Lead
Ajinomoto Bio-Pharma Services
04.2015 - 04.2016
Senior Quality Control Associate
Ajinomoto Bio-Pharma Services
04.2013 - 04.2015
Quality Control Associate
Ajinomoto Bio-Pharma Services
01.2010 - 04.2013
Senior Quality Control Assistant
Ajinomoto Bio-Pharma Services
01.2008 - 01.2010
Quality Control Assistant
Ajinomoto Bio-Pharma Services
02.2006 - 01.2008
San Diego State University
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