Qc Microbiology

Carmen Romero

* ********* ****

Lawrence, MA ****3

(Cell) 978-***-****

Email: **********@*****.***

CAREER OBJETIVES:

Accomplished individual seeking a microbiologist position where I can utilize my education, professional experience, and motivational skills in a biotechnology industry.

QUALIFICATIONS SUMMARY:

Result-oriented and motivated Microbiologist in a Quality Control Biotechnology field with excellent interpersonal skills with the ability to multi-task and work independently. Very experienced with Good Laboratory practices (GLP)

Pharmaceutical Current Good Manufacturing Practices (cGMP), and FDA guideline. Proficient Development, execution and training of procedural documents to all levels of personnel in inter and intra laboratory departments.

RELATED SKILLS:

Experience working with LAL bioburden, Growth Promotion, TOC, Conductivity, Sterility Testing, Gram Stain, plate enumeration, Environmental Monitoring, B&F.

Proficient with writing and executing Standard Operating Procedures.

Strong ability to effectively communicate processes and procedures.

Preparation and execution of laboratory experiments.

Outstanding organizational skills on handling multiple assays and projects.

Extensive experience in GLP, cGMP atmosphere.

Proficient with document records training.

Trained on particle count.

Ordering and maintaining all lab supplies

PROFESIONAL EXPERIENCE:

Pace 13Insdusrial way, Salem NH 03079 Feb2020 to Present

Oversees all Microbiological assays in support of manufacturing according to USP/EP regulations.

Receiving and performing all related testing for final products and Stability samples.

Bioburden testing for water and in-process samples

Oversee all lab procedures

Scheduling and performing LAL, GPT, Environmental Monitoring Sterility testing by membrane filtration and direct Trasfer

Review batch records and routine data for validity and compliance to current Good Manufacturing Practices (GMPs)

and Standard

Operating Procedures (SOPs)

Perform method validations and qualifications related to sterility, endotoxin and bioburden testing

SME/Provide training qualification for aseptic gowning, environmental monitoring, bioburden, sterility, endotoxin (Kinetic Turbidmetric)

growth promotion,

Responsible for Deviation and updating Standard Operation procedures to ensure the Microbiology Department is up to date with compliance and regulations

Northeaster Arc Danvers, MA April 2016 to Feb 2020 (Part time)

Personal care aides generally responsible, for cooking, running errands, laundry, as well as assisting client with

bathing, showering, grooming, and other personal hygiene tasks. Accompanying to medical appointments Organize

medicines making sure all are taken on appropriate time

QC Team Leader Microbiologist Pharmalucence Inc., Bedford MA

Dec 2005 - Nov 2015

Oversees all Microbiological assays in support of manufacturing according to USP and EP regulations.

Bioburden testing for water and in-process samples

Generate daily/weekly schedule for Quality Control group

Responsible for interviewing and hiring new personnel

Responsible for reviewing final products batch records

Oversee all lab supplies and procedures

Reviewing and updating all the existing Sops

Scheduling and performing LAL, GPT, Environmental Monitoring Sterility testing by membrane filtration and direct inoculation

QC Senior Analyst

Antigenics Inc. Lexington MA

Feb 2003-Dec2005

Responsible for daily operations of the QC/ Microbiology lab to ensure the following assays are performing according to GMP’s and GLP’s regulations for Sterility, Endotoxin and Bioburden testing for water and in-process samples, TOC, Conductivity, Gram Stain, and Growth Promotion Testing.

Perform B&F Testing.

Performed Environmental Monitoring

Validated new facility

Revised and updated Sops

Analyst IV Organogenesis Inc.

Canton, MA

May 1998-Feb-2003

Responsible for daily operations of the QC/ Microbiology lab to ensure the following assays are performing according to GMP’s and GLP’s regulations for Sterility, Endotoxin and Bioburden testing for water and in-process samples, Gram Stain, and Growth Promotion Testing.

Generated weekly schedule for the QC Group

Scheduled and performed environmental monitoring and validation program for all the EU suites

Provided lab training for all new personnel

Revised and updated Sops

Responsible for interviewed and hired new employees

Education:

Middlesex Community College

Bedford, MA

Relevant course work: Microbiology, Biology, Chemistry, English, and Methods in Biotechnology and Advanced Techniques in QC GMP for the Biotechnology Industry.

Training and Seminar

GMP training

Biohazard training

Radioactive training

LAL training

References Available Upon Request

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