YIRENI FRICA
Paterson,NJ
Summary
Quality Assurance professional with 10+ years of experience in pharmaceutical manufacturing and operations, including 5+ years of progressive experience in Quality Assurance. Experienced in cGMP-regulated environments, with a strong background in quality systems, compliance, batch review and disposition, document control, and sterile manufacturing. Proven ability to work cross-functionally to support product quality and regulatory requirements.
Overview
16
16
years of professional experience
Work History
Quality Assurance Compliance Specialist
Imprimis Rx Pharmaceutical
Ledgewood, NJ
09.2023 - Current
- Support Quality Assurance and cGMP compliance activities within a pharmaceutical manufacturing environment, ensuring adherence to applicable regulations, approved procedures, and quality requirements.
- Perform batch record review and batch disposition using electronic batch records (eBR) and MasterControl, evaluating manufacturing documentation for completeness, accuracy, compliance, and readiness for release.
- Review Certificates of Analysis (CoAs) and other supporting quality documentation to verify compliance with approved specifications and batch release requirements.
- Create and maintain product lots in electronic systems and ensure required batch and quality documentation is uploaded, complete, and available to support timely product release.
- Generate and maintain batch release documentation and certificates of release in accordance with established procedures and Quality System requirements.
- Review and resolve documentation discrepancies and quality issues identified during batch review, collaborating with Quality, Manufacturing, QC, Pharmacy, Operations, and other cross-functional teams to support timely batch disposition.
- Support Annual Product Quality Review (APQR) activities, including compilation and review of applicable product and quality data.
- Draft, revise, and maintain SOPs, work instructions, and other controlled Quality documentation in accordance with cGMP and Quality System requirements.
- Support CAPA and other Quality System processes, including documentation, follow-up, effectiveness activities, and implementation of quality improvements.
- Utilize Veeva Quality and MasterControl to manage controlled documentation, workflows, batch records, and Quality System activities while maintaining accurate and traceable records.
- Support continuous improvement initiatives to improve the efficiency, consistency, and effectiveness of QA and batch disposition processes.
- Support FDA, Board of Pharmacy, internal, and external audits and inspections through document preparation, record retrieval, response coordination, and cross-functional support.
- Coordinate product recalls, returns, and destruction activities, including distribution reconciliation, inventory verification, returned product tracking, consignee communications, and required documentation.
- Support adverse drug event (ADE) intake, follow-up, documentation, and applicable regulatory reporting.
- Coordinate state facility licensing activities, including regulatory submissions, renewals, supporting documentation, and tracking of licensing requirements and expiration dates.
- Prepare, review, submit, and track controlled substance reports required by applicable state regulatory authorities.
Quality Assurance & Documentation Specialist
07.2021 - 09.2023
- Coordinated and supported the operation, maintenance, and continuous improvement of the Quality Document Control System.
- Edited and formatted controlled documents and initiated and managed document approval workflows.
- Assigned effective dates to approved documents and coordinated required training notifications.
- Maintained, tracked, archived, and organized Quality records in accordance with document lifecycle and record-retention procedures.
- Coordinated periodic reviews of controlled documents and collaborated with cross-functional teams throughout document revision and approval processes.
- Tracked and trended Quality data to support Quality metrics and management reporting.
- Identified, led, and supported process improvement initiatives within Quality Assurance.
Sterile Production Technician
10.2017 - 07.2021
- Performed aseptic pharmaceutical manufacturing activities including weighing, equipment setup, mixing, homogenization, sterile filling, and cleaning within ISO-classified areas.
- Followed cGMP requirements, approved SOPs, Batch Production Records (BPRs), and applicable Quality requirements.
- Completed Batch Production Records and equipment logbooks accurately and contemporaneously.
- Operated pharmaceutical manufacturing equipment including automated filling lines, washers, ovens, filter integrity testers, and autoclaves.
- Followed gowning, aseptic technique, and contamination-control procedures within sterile and controlled environments.
- Cross-trained in inspection and labeling operations and collaborated with Quality, Production Support, and Maintenance.
- Participated in root cause investigations related to deviations and identification of potential CAPA.
Non-Sterile Pharmacy Technician
11.2015 - 10.2017
- Prepared non-sterile compounded medications including suspensions, solutions, tablets, capsules, troches, powders, ointments, creams, and gels.
- Used computerized compounding systems to weigh, measure, document, and prepare pharmaceutical ingredients according to approved procedures.
- Maintained non-sterile compounding areas in accordance with established procedures.
Pharmacy Technician
Saint Joseph Regional Medical Center Inc.
Paterson, NJ
06.2010 - 11.2015
- Prepared, filled, and delivered medications, floor stock, exchange carts, and emergency medication trays.
- Stocked Pyxis MedStation systems, including controlled substances.
- Followed procedures for controlled substance handling, waste, documentation, and accountability.
- Prepared intravenous admixtures and other sterile preparations utilizing aseptic technique in accordance with USP requirements.
- Monitored inventory and removed expired medications according to departmental procedures.
Education
Bachelor of Arts - Biology (General Option)
Kean University
Union, NJ2027
Biology Coursework -Transferred To Kean University -
Passaic County Community College
Paterson, NJ09.2025
Pharmacy Technician Certificate -
Berdan Institute
Wayne, NJ05.2010
Skills
- Veeva Quality Systems
- SOP Management
- Quality Assurance
- CGMP Compliance
- Document Control
- MasterControl
- Quality Metrics
- Audit & Inspection Support
- Aseptic Manufacturing
- Regulatory Compliance
- Batch record Review & Disposition
- CAPA
- State Licensing
- Product Recalls
- ADE Reporting
- Controlled Substance Reporting
- APQR
- Bilingual: English and Spanish
- Microsoft Office
Timeline
Quality Assurance Compliance Specialist
Imprimis Rx Pharmaceutical
09.2023 - Current
Quality Assurance & Documentation Specialist
07.2021 - 09.2023
Sterile Production Technician
10.2017 - 07.2021
Non-Sterile Pharmacy Technician
11.2015 - 10.2017
Pharmacy Technician
Saint Joseph Regional Medical Center Inc.
06.2010 - 11.2015
Bachelor of Arts - Biology (General Option)
Kean University
Biology Coursework -Transferred To Kean University -
Passaic County Community College
Pharmacy Technician Certificate -
Berdan Institute