Anna Garcia De Alba
San Diego
Summary
Quality Assurance professional with experience in ensuring product excellence and compliance. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in quality control processes, problem-solving, and maintaining high standards. Known for reliability and effective communication.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Associate I
Pacira Biosciences
06.2023 - Current
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP).
- Reviews and processes cGMP documentation and data to ensure accuracy, compliance, and completeness, including logbooks, rinse water samples, and sterility forms
- Assists in the identification of risk and deficiencies while working with internal departments and business units to appropriately remedy them.
- Lead Deviation Investigations to ensure timely resolution and compliance with GMP guidelines.
- Conduct Internal Gap Assessments to proactively identify areas of improvement within quality operations.
- Facilitates internal training on quality assurance requirements, processes, and procedures.
- Represent QA during production activities.
- Conduct quarterly audits of cleanroom areas to assess compliance with GMP standards, identify potential risks, and ensure adherence to contamination control protocols. EHS representative of the Quality Assurance Team.
- Provide floor support for GMP activities.
- Monitor for GMP compliance of all in-process activities during GMP processing.
- Perform AQL particle inspection of in-process product vials prior to packaging.
- Sterile gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
- Perform review of executed Batch Documentation and prepare for disposition.
- Perform all process steps for the Transfer and Shipment of Batch Records.
- Ability to search, document and generate quality event reports for Batch Release.
- Processing of QA Holds.
- Maintain databases as required.
Manufacturing Quality Assurance Associate II
ABZENA
07.2022 - 01.2023
- Provided QA oversight during manufacturing processes.
- Conducted real time review of Batch Record documentation.
- Executed floor audits to ensure compliance with regulatory and industry standards.
- As a subject matter expert, provided guidance and support to the production team to ensure efficient and effective operations.
- Assisted on the implementation of CAPAs.
- Escorted clients during audits and guided them through the clean room areas, providing a thorough understanding of the facility's compliance and safety protocols.
- Performed Area Clearances for Manufacturing processes.
- Implemented manufacturing expertise to make real-time decisions in accordance with regulations and procedures.
- Assisted during creation and initiation of cGMP documentations. (e.g. SOPs, Batch Records, Process Forms)
- Reviewed and approved initiation of Deviations.
- Sterile Gown qualified to support cGMP activities in sterile suites. (ISO 5-7)
- Performed real-time review of Buffer Batch Records.
- Approved and generated Buffer release labels.
- Processed cGMP documentation and data review. (e.g logbook, batch records, sterility forms)
- Guaranteed safety protocols and guidelines were followed during process.
Manufacturing Quality Assurance Associate II
Ajinomoto Bio-Pharma Services
05.2019 - 06.2022
- Delegated intake of phone inquiries to the appropriate individuals.
- Performed real time, on the floor documentation review during commercial packaging and labeling activities.
- Generated and reviewed labels for cGMP use.
- Reviewed, approved, and generated Buffer release labels.
- Provided on the floor support for Buffer operations by reviewing Buffer Batch records real time.
- Reviewed and approved Stability Reports.
- Sterile gown qualified to support cGMP activities in sterile suites.
- Oversaw scheduled facility walk-throughs.
- Processed cGMP documentation through initiation, revisions, and deletions. (e.g. SOPs, Buffer Batch Records, Cleaning Logs).
- Assisted in the review and approval of executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product batches.
- Assisted in real-time review of documents on the manufacturing floor.
- Performed Line Clearance operations in support of manufacturing processes.
- Designated subject matter expert during AQL inspection.
- Managed the documentation/data review in support of manufacturing operations (e.g. logbooks, cleaning logs, sterilization records).
- Provided training to new employees on daily activities and documentation review.
- Document Project Manager of Drug Substance, Stability Reports, Logbooks, and Cleaning Logs.
- Generated monthly data metrics reports with key performance indicators and actionable insights.
- Provided GMP training to other departments.
- Assisted other departments with corrections and GMP questions.
- Provided Media Oversight for Visual Inspection.
- Prepared responses to customer requests.
- Safety Coordinator.
- Runner for Client and FDA Audits.
Education
Associate of Liberal Arts - Emphasis in Math and Science
SouthWestern College
Chula Vista, CA01.2015
Bachelors - Public Health
University of California San Diego
San Diego, CA01.2018
Skills
- Bilingual
- GDP/ GMP Knowledge
- Proficient in MS Office
- Strong aptitude for detail, accuracy, and organization
- Internal Auditing
- Quality Risk Assessment
- Effective communication skills
- Proficient in managing electronic data through Master Control, ACE, ESI, and ZenQMS
- Aseptic technique (ISO 5-7)
- FDA 21 CFR Parts 210 & 211
- Meticulous attention to detail, ensuring accuracy and completeness in all tasks and responsibilities
Certification
- First Aid & CPR AED Certified DEC/2026
- HSI/ Health and Safety Institute
- First Aid, CPR, AED for Adults, Children, & Infants
- Lean Six Sigma Yellow Belt FEB/2021
- Six Sigma Global Institute
- Generate analysis on data metrics to effectively implement solutions.
- Acquired knowledge of defining processes, quality control, problem-solving, and eliminating waste.
Timeline
Quality Assurance Associate I
Pacira Biosciences
06.2023 - Current
Manufacturing Quality Assurance Associate II
ABZENA
07.2022 - 01.2023
Manufacturing Quality Assurance Associate II
Ajinomoto Bio-Pharma Services
05.2019 - 06.2022
Bachelors - Public Health
University of California San Diego
Associate of Liberal Arts - Emphasis in Math and Science
SouthWestern College
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