RUCHITA RANA
Passaic,NJ
Summary
In-depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.
Overview
4
4
years of professional experience
Work History
QA Associate II
Minaris Regenerative Medicine
08.2023 - Current
- Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical, and commercial manufacturing
- Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical, and commercial manufacturing
- Release raw material on the ERP system as well as on paper
- Perform Accessioning of incoming Apheresis
- Issuance of pre-clinical and clinical master batch records and labels
- Review the Batch record and disposition of material of the finished product to the client
- Provide information for Out of Specification and deviations to the investigator
- Writing reports for any Notification of Event (NOE)
- Perform line clearance prior to manufacturing operations begin.
QA Specialist
Celularity
01.2022 - 03.2023
- Celularity
- Verify that thebatch production records adhere to approved procedures and GMP requirements
- Review and Release batches of commercial lots
- (Batch review checklist, creation of COA)
- Work Collaboratively with Internal Staff to Respond to And Resolve Manufacturing Deviations
- Check to see that High-Quality Event Activities have been completed
- Work with the appropriate personnel to discuss and resolve any discrepancies or errors
- Offer suggestions and input for modifying and enhancing procedures and processes
- Handle product-related Quality Events such as change controls and investigations
- Assist with the Reporting and Presentation of Department Metrics
- Review Standard Operating Procedures
- Worked with cross-functional teams to address product issues, define, and implement effective corrective actions and monitor post-implementation effectiveness
- Trained new hires on daily job functions and responsibilities.
- Fixed identified issues to improve workflows.
QA Associate
Celularity
07.2021 - 01.2022
- Conduct QA review of various product-related records for completeness and accuracy according to SOP (e.g., batch records, QC data, donor eligibility)
- Conduct QA verification and reconciliation of product packaging and labeling (Biobanking/ Tissue manufacturing)
- Provide input/suggestions for revising and improving processes and procedures
- Review batch records Biobanking/ Biomaterials
- Trained newly hired employees by explaining job duties and performance expectations
- Initiation of batch-related deviations
- Trained in laboratory Gowning Procedures
- Support incoming material inspection and release
- Experience with electronic quality systems and enterprise resource planning systems (Veeva and GP).
- Educated employees on specific QA standards and confirmed maintenance of standards.
QA inspector
Nutra-med Packaging Inc
12.2019 - 07.2021
- Inspected the quality of finished products, making minor repairs to meet project expectations
- Assessed materials, parts, and products for conformance with quality control requirements and production specifications
- Completed non-destructive tests and visual inspections continuously
- Wrote detailed reports outlining performance and quality defect rates
- Trained newly hired employees by explaining company procedures, job duties, and performance expectations
Education
Bachelor of Science - APPLIED MANAGEMENT
Grand Canyon University
Phoenix, AZ01.2024
Skills
- Production experience
- Training mentorship
- 21CFR 13712
- CGMP, cGTP, GxP
- Problem-Solving
- Team Leadership
- Detail-oriented
- Analytical Thinking
- Internal Audits
- Collaboration Skills
Timeline
QA Associate II
Minaris Regenerative Medicine
08.2023 - Current
QA Specialist
Celularity
01.2022 - 03.2023
QA Associate
Celularity
07.2021 - 01.2022
QA inspector
Nutra-med Packaging Inc
12.2019 - 07.2021
Bachelor of Science - APPLIED MANAGEMENT
Grand Canyon University
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