Quality Control Manufacturing Technician

Steve Lempitski

Bellingham, MA ***** 508-***-****

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

QC Analyst/Manufacturing Technician

Summary

Results-focused leader with strong analytical skills and extensive experience in biotech industry within FDA regulated companies. Proven success consistently delivering exceptional results and achieving high-level customer satisfaction at sites. General knowledge of GMP, ISO, standard manufacturing practices, testing methods, and guidelines. Adept at monitoring production process while ensuring efficiency and quality. Demonstrated ability to operate pilot-scale bioprocessing equipment, analytical testing instrumentation and assist in the operations of a manufacturing facility.

Areas of Expertise

Research & Development

Technology Transfer

Customer & Account Service

Audits & Inspections

Regulatory Compliance

Aseptic Manufacturing

Trackwise

Team Training & Leadership

Relationship Building

Operational Excellence

Process Improvement

Documentation & Reporting

Validation

Veeva

Revenue Growth

Safety Standards

Cost Control

SOP Writing

Risk Analysis

Microbiology

Change Control

Accomplishments

Qualified GMP critical instrumentation for manufacturing and product release use.

Developed and taught a testing method at FDA headquarters for testing eyewash solutions for fungal contamination.

Conceived and implemented a manufacturing improvement that streamlined a manufacturing process that realized a $50K savings in materials coupled with the personnel costs for an entire shift.

Professional Experience

Rentschler Biopharma, Milford, MA May 2023 – Present

QC Microbiology Analyst II

Hands on bench technician in microbiology group for raw materials and in process drug substance testing in a CDMO facility. Author and execute validation protocols for new instrumentation, method transfer and development of testing methods for newly acquired product line.

Authored and executed validation protocol to qualify plate reader for bacterial endotoxin testing.

Developed, characterized, and validated endotoxin testing methods for new drug substances.

Trained and mentored analysts in instrument use and testing methods.

National Resilience/Sanofi Genzyme, Allston, MA Sep 2016 – Apr 2023

Quality Control Analyst Principal

Oversee certification and release of GMP-critical equipment in chemistry and microbiology labs at Allston Landing site. Create maintenance and operational SOPs; author and execute validation protocols. Develop operational and technical skills of allocated personnel through training. Ensure that the company meets exact standards for all products. Demonstrate knowledge of 21 CFR part 11 regulatory expertise.

Authored and executed validation protocols for GMP Critical instrumentation for manufacturing and product release.

Authored Use and Maintenance SOPs, Method SOPs, and Training Documents.

Originated Change Controls, Risk Assessments, Deviations, Non-Conformance Reports and CAPAs.

Trident Biosystems, Kowloon, Hong Kong Dec 2012 – Aug 2016

Technical Specialist

Supervised aseptic production of final goods for the startup company with an emphasis on high-quality products. Tested final release and assessed raw components; reviewed and improved strategies for quality control; wrote SOPs and developed and optimized final formulations. Determined operational and technological requirements; applied effective tactics and techniques. Consulted high management on process modifications and quality enhancements.

Led regular training sessions at customer sites on pharmaceutical producers and aseptic manufacturing for staff to achieve prominent level organizational and technical proficiency.

Provided FDA regulatory experience to help the company fulfill exacting standards for all goods.

Diagnosed and addressed technological concerns and challenges for various clients.

Additional Experience

Instrumentation Specialist/Technical Specialist - Customer Complaints/General Supervisor - Beacon Diagnostics/Product Development Specialist/Quality Control Technician/Technical Services Representative/Manufacturing Technician, Associates of Cape Cod, Falmouth, MA

Quality Control Specialist, Lab Support, Burlington, MA

R&D Supervisor, Solvay Animal Health, Grafton, WI

Technical Support Representative, Clinical Assays (Baxter Healthcare), Cambridge, MA

Education & Credentials

Bachelor of Science in Biology

Boston College, Chestnut Hill, MA

Skills Summary

Offer 20+ years of in-depth experience in multiple testing methods and guidelines: Sterility, Microbiology, Water Quality, Cell Culture, HPLC, GC, UV Spectroscopy, FP, Endotoxin, TOC, PCR, ELISA, Validation, Aseptic Technique, CLIA, FDA, HIPAA, USP.

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