Lissette Montalvo

Boynton Beach, FL ***** •561-***-****• acgg3p@r.postjobfree.com

Quality Assurance/Process Development Professional

Proven record of success with increasing responsibilities. Several years of experience in the Pharmaceutical and

Bio-Pharmaceutical Industries with extensive knowledge in Quality Assurance, Product Development,

Manufacturing Process Inspection and Cleaning Validation Engineering. Experienced with internal inspections

following regulatory agencies such as FDA compliance (CFR-21 parts 210 & 211), European Medicine Agency

(EMA).

Professional Experience:

Biotest Pharmaceuticals – Boca Raton FL, 10/2008-08/2014

Biotest Pharmaceuticals is a subsidiary of Biotest AG, a German-based global provider of plasma protein

therapies.

Quality Assurance Specialist 04/2012 – 08/2014

• Performed Intermediates, and Final product shipping inspections and internal audits, of Manufacturing and

QC Laboratory facilities to meet and ensure quality of GMP compliance.

• Advised, controlled, reviewed, revised red-line, and approved QA-GMP department documentation (e.g.

Internal, Change Controls, Audit Documentation, Procedural requirements of Batch Records/ Process

documents such as Standard Operations Procedures (SOPs), Cleaning Validation Protocols and Final

reports, Deviations, Environmental Deviation Reports (EDRs), (CAPA’s, etc.).

• Collaborated in the development, scale up, BLA submission and FDA approval of Bivigam, a new product

designed for immune-deficiency patients.

• Reviewed and approved 25+ Cleaning Validation Protocols with consistent quality within limited time

frame to meet FDA standards and Master Plan.

• Facilitated with various internal and FDA inspections.

• Compiled consistent updated and tracked audit/inspection reports to maintain FDA compliance.

• Produced an updated department tracking log in excel spreadsheets on a weekly basis.

• Collaborated with product submission studies in Final Reports and Protocol executions to meet deadlines of

BLA submissions.

• Interacted internally with department’s management team such as; (Quality Control, Manufacturing,

Process Development, Regulatory Affair, Metrology, and Maintenance) to ensure GMP compliance with

operating procedures and current industry standards.

• Conducted internal investigation of failures; write deviation reports and make recommendation for

corrective actions.

• Ensured compliance with plasma related regulatory requirements with specific testing results identifying

infected plasma.

• Created Certificates of Analysis, Certificates of Compliance, and Lot Dispositions for company products.

Process Development Technician 07/2008 – 04/2012

• Developed Cleaning Validation Protocols for a GMP regulated FDA licensed product, wrote and executed

cleaning validation protocols, final reports, for manufacturing equipment.

• Launched the Cleaning Validation Engineering for the Validation campaign with completed success of 40+

protocols and related deviations.

• Executed robustness, mixing, and buffer studies for the process of the company for product optimization

(IGIV/ Bivigam) by making ethanol concentration changes and pH adjustments.

• Implemented new process methods for making products at a small scale and evaluating existing processes

to identify areas for improvement with 20+ project executions.

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• Finalized the Manufacture process of plasma products through protein separation, Fractionation,

Purification, Centrifugation, Ultrafiltration, Chromatography, and Nanofiltration.

• Worked in sterile environments filling product and environmental monitoring.

• Managed a wide variety of research laboratory tasks and experiments, making detailed observations,

analyzing data, and interpreting results.

• Experienced with Quality Systems such as, Root Cause Corrective Action training, Deviations, and Protocol

approvals.

• Improved yields of increasing plasma product from 10-15% while reducing costs, for example investigating

alternative new machinery to improve efficiency for testing (alcohol testing instruments).

• Internal liaison with suppliers of raw materials to resolve production problems related to raw materials that

affected the manufacturing process.

• Conducted test protocols and procedures, and product evaluation to maintain quality of the product.

• Maintained laboratory equipment and inventory for laboratory supplies.

• Trained 5-10 employees of manufacturing in the product process.

Horizon Pharmaceuticals (Formerly known as Vital Pharma) – Riviera Beach FL, 07/2007 – 07/2008

Quality Control Chemist

• Performed QC testing to evaluate chemical ID testing and physical properties of various OTC’s such as

eyewash, eye saline, and eye lubricants in a GMP regulated pharmaceutical sterile environment.

• Assisted in Out of Specification investigations, validation, sampling raw materials and component testing

and release.

• Performed Chemical Quality Control analysis of WFI, Raw Materials testing, Work in Process, and Finished

Goods sample.

• Performed QC Analysis for pH, Osmolality, Viscosity, HPLC, TOC, TIC, FT-IR, UV/VIS

spectrophotometer, Particle air counter (RCS), Chemical Identification, and potency assays, cross-trained in

Microbiology work.

• Data reporting and reviewed, SOP generation and review, method and development, perform preventative

maintenance.

• Prepared reagents and solutions, and troubleshoot instruments.

Education:

• CMBA, Corporate Masters of Business Administration- Florida International University

• B.A., Biological Science – Florida Atlantic University

Skills and Strengths:

• Computer Proficiency: MS Microsoft, MS Excel, MS PowerPoint and MS Outlook

• Type at approximate 45 – 50 wpm

• SAP (System Applications and Programs), EDMS (Master Control Systems), Lims (Labvantage Sapphire

system)

• Detail oriented

• Good verbal and written communication skills

• Effective interpersonal / interdepartmental skill

• Committed to quality & integrity

• Team oriented

• Proactive at developing solutions in competing priorities and multi-tasking

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• Work well independently and in a team environment with minimal supervision required

• Very disciplined and eager to absorb new information

• Fluent bilingual, English and Spanish verbally and written

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