Quality Control Analyst

MARIA ROSARICA PERUCHO

*** *. ******* ****., **** 303 Pomona, CA 91766

Cell: 626-***-****

***********@*****.***

OBJECTIVE

Conscientious and highly motivated QC analyst with over ten years of experience looking to leverage extensive knowledge and hands-on experience in cell based derived biologic assays for a stable and growth-oriented gene and/or cell therapy manufacturing company.

KNOWLEDGE AND SKILLS

●In depth knowledge of Quality Control laboratory principles, theories, concepts and techniques acquired through training and experience working for biotechnology, pharmaceutical companies.

●Knowledge and experience in Quality Control laboratory activities that relates to method suitability testing, instrument/method qualification (IQOQPQ), instrument verification runs and validations.

●Working knowledge of Laboratory Information Management System (LIMS).

●Knowledge and experience writing SOP’s, protocols, test methods and the like.

●Working knowledge of cGMP, GLP, GDP, LEAN 5S guidelines, QSR, USP pharmacopeia and FDA guidance applicable to cell derived biologics and cell therapy.

●Cell culture processing experience in handling and propagation of primary cell line.

●Proficient in MS Office.

●Detail oriented with ability to multi-task and handle multiple responsibilities simultaneously.

●Hard worker, organized, efficient and conscientious.

PROFESSIONAL EXPERIENCE

June 2019 – NKMax America Inc. Santa Ana, CA

QC Analyst II QC -Bioassay

Supports manufacturing process by conducting biological, chemical and physical analyses of raw materials, stability samples, in-process and final product testing utilizing the following instruments and methodologies:

BD Lyric for FACS (Fluorescence-activated cell sorting), Charles River Endosafe™ Nexgen PTS and MCS reader for Bacterial Endotoxin testing (LAL), PREVI® Color Gram V2 for Gram Stain, Lumat LB9708 for Mycoplasma by MycoAlert® assay, E-Gel™ Power Snap Electrophoresis system for Mycoplasma by PCR, Spectra Max reader for Calcein Assay, Automate Express (Thermo Fisher) for qPCR, IL-21 ELISA, Gentamicin ELISA, and FBS ELISA for residual testing, and BacT/Alert 3D for sterility testing.

Cell passaging and maintenance of K562 cell line used for calcein-AM cytotoxicity assay of NK (natural killer) cells.

Writes, revises, and reviews sops, test methods, and protocols.

Participant in the method qualification for the following instruments: BacT/Alert 3D for sterility testing, PREVI Color Gram V2 for gram staining and Charles River Endosafe ® Nexgen PTS and MCS readers for bacterial endotoxin (LAL).

Trainer for bioassay testing specifically for gram staining, bacterial endotoxin (LAL), mycoplasma by mycoAlert™ and mycoplasma by PCR.

Manages the procurement of equipments/instruments, materials, reagents and consumables for the QC department (bioassay and microbiology).

Coordinates and communicates with vendors regarding equipment/instrument acquisitions, training schedules, instrument verification, validation and calibration, method and assay qualifications.

April 2016 – May 2017 Bio-Rad Laboratories Irvine, CA

QC Chemist QC Department-Immunology Group

Responsible for stability testing and sending out control samples to independent laboratories per final product testing protocol.

Responsible for reviewing and finalizing batch records before product release.

Assigns daily testing work schedule to 4 laboratory technicians in the QC Immunology group.

Performed data analysis, validate test data and perform data entry and review of test results into LIMS.

Assist shift supervisor in evaluation and implementation of QC test procedures and departmental processes.

Initiates Quality Notifications (QN), such as Assay Exception Reports (AER), Procedure Exception Reports (PER) and Non- Conformance Reports (NCR) related to product OOS, process deviations, stability testing OOS as needed per final product release testing protocol.

August 2010- January 2015 Dendreon Corporation Seal Beach, CA

QC Associate I QC Bioassay Grp

Conducted testing support through all stages of the manufacturing process from incoming raw materials, in-process through final product testing using the following instruments and methodologies:

CBC (BeckmanAct5 Diff), manual differential, cell viability (trypan blue), cellometer, bacterial endotoxin (LAL KQCL assay), ELISA, rapid ELISA, gram stain, and flow cytometry (Beckman Cytomics FC500 MXP).

Trained and certified to conduct PBMC cryopreservation on DN24-02 (clinical trial samples) for product characterization.

Qualified as analyst, reviewer and trainer for CBC, viability, gram stain, bacterial endotoxin (LAL), ELISA and rapid ELISA.

Participant in the quarterly QC stability testing.

Receives and maintains test samples, prepares/qualifies reagents and reference standards used in the QC laboratory per approved TM/SOP.

Complies with EHS guidelines, cGMP, GLP, GDP and QSR.

Ensures work environment is clean and safe implementing Lean 5S principle.

Performed routine laboratory daily, weekly and monthly equipment and instrument calibration and maintenance.

Performed laboratory instrument validation (IQ, OQ, PQ) for CBC analyzer (Beckman Act5 Diff) during company startup.

Chosen as one of two receiving analyst for ELISA and bacterial endotoxin testing (LAL) for the method transfer validation.

Initiates and investigates corrective and preventive actions (CAPA) as needed as well as trains and mentors newly hired QC associates.

Reviews lot files, initiates Laboratory Investigation Reports (LIR) and/ or Exception

Reports (ER) for invalid assays and OOS as needed.

February 2007 – October 2009 Vital Diagnostics Inc. Brea, CA

Senior QC Chemist QC Department

Conducts testing for In-coming raw materials and bulk OEM products.

Conducts In-process and Finished Product testing using the following instruments and methodologies:

pH meters, titration, Spectrophotometers, ATAC 6000, ATAC 8000, Envoy 500, Selectra E, Selctra XCel, Beckman CX3, Hitachi 717, Beckman Ion 4, Beckman Glucose Analyzer.

Conducts IQA inspections for labels, package inserts, raw materials and OEM products.

Prepares assay reagents, buffers, stock standards and pilot batches for testing.

Responsible for all QC laboratory proficiency testing (CAP and API).

Responsible for linearity testing, test method validation and product expiration date extension.

Reviews and signs out lot files.

Responsible for the training and mentoring of newly hired QC personnel.

July 2004 – February 2007 Vital Diagnostics Inc. Brea, CA

QC Chemist QC Department

Conducts in-process and finished product testing using the following instruments: pH meters, Spectrophotometers, ATAC 6000, ATAC 8000, Envoy 500, Selectra E, Selectra XCel, Beckman CX3, Hitachi 717, Beckman Ion 4 and Beckman Glucose analyzer.

Conducts IQA inspections for labels, package inserts, raw materials and OEM products.

Prepares assay reagents, buffers and stock standards for testing.

Conducts testing for in coming raw and bulk materials.

OTHER TRAINING

April 2005 Current Good Manufacturing Practices Pasadena, CA

(Trained/Certified)

REFERENCES

Available upon request

Contact this candidate