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Quality Assurance Testing

Location:
Algonquin, IL
Posted:
August 11, 2013

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Resume:

OBJECTIVE

To obtain a challenging position as a Microbiologist utilizing my strong

science background and organizational skills with a company that offers

opportunities for growth and advancement.

SKILLS

. Experienced working in sterile laboratories (Maneesh Pharmaceuticals

Ltd).

. Hands on experience in basic and advance laboratory techniques.

. Demonstrates a good knowledge of microbiological theories, concepts

and principles. Good knowledge of microbiology, biochemistry and

chemistry is essential.

. Experience in wide range of microbiological techniques including

handling of bacterial and fungal cultures, aseptic procedures,

streaking and plating techniques for isolation of colony forming units

required.

. Experience with pharmaceutical microbiology such as preservative

effectiveness, sterility, microbial limits, and endotoxin

. Experience in operation of standard microbiology instruments such as

microscopes, spectrophotometers, biohazard safety hoods, refrigerated

centrifuges, autoclaves and pH meters required.

. Self-motivated and shows willingness to take on new

approaches/technologies and additional responsibilities.

. Ability to work as team member and as a team leader. Self-motivated,

quick learner and detail oriented. Outstanding interpersonal skills,

good communicational and analytical/problem solving skills

. Well conversant with Microsoft office (Word, Excel, PowerPoint,

Access)

EDUCATIONAL QUALIFICATIONS

MS Microbiology, 2001

PROFESSIONAL EXPERIENCE

Lecturer 2008-2011

DMP Educare, India

Basic Biology and Microbiology

Basic laboratory techniques like gram stain, streaking plate

Microscopy

Use of common lab equipment like Ph meter, autoclave, incubators etc.

Concepts of Sterility

Microbiologist II (QC) 2003-2006

Maneesh Pharmaceuticals Ltd, India, Mumbai

Hands on experience in

Sterile/clean room procedure

Gowning procedure

Environmental monitoring in the testing and production room

Raw material/ In-process/ water bioburden testing

Sterility testing of finished product and raw product

Microbial enumeration of finished product and raw product

Experienced in antimicrobial sensitivity testing, MIC, MRSA testing and

endotoxin LAL testing

Preservative efficacy testing and Microbial Identification (MIS) testing

Monitoring and calibration of lab equipments (autoclaves, pH meters, water

baths, incubator etc.) in order to keep within regulatory compliance

Maintained controlled documentation files (e.g. training records, copies of

batch records, product specs/test methods, audit records, investigation

records, stability data/reports), product compliance files

Compiled, organized and maintained reference materials (i.e. Master Product

Binders, approved packaging, regulatory/QA updates)

Prepared Method Validation protocol, draft methods, testing specifications

and method Validation summary reports

Drafts and revises Standard Operating Procedures and Quality Assurance

Laboratory Procedures.

Followed all QC procedures for department and Quality Reporting

Adhered to all SOPs & GMPs and regulatory requirements. Documented and

reported results as per established SOP

Lecturer (2002 - 2003)

Yerala Dental College, India

General Microbiology and Oral Microbiology.

Isolation and identification of microbes from saliva, plaque and tartar

(Spirochetes, Streptococcus etc

Sterilization of apparatus, slide preparation

Aseptic cell transfers and media preparation for analysis

Gram stain, Differential staining

Microscopy

Microbiologist (QC Department) 2001 - 2002

SIES-Environmental Management Institute, India

Hands on experience in the following:

Sterilization of apparatus, slide preparation and staining

Aseptic cell transfers and media preparation for analysis

Environmental monitoring, sampling and testing

Isolation and identification of microbes (Bacterial, Listeria, Salmonella,

E. coli, S. aureus, Yeast and Fungal colonies)

Water microbiology tests: HPC, total Coliform/E. coli, fecal Streptococcus

and Pseudomonas aeruginosa determination using the MPN and Membrane

Filtration techniques.

Experienced in antimicrobial sensitivity testing, MIC, MRSA testing and

endotoxin LAL testing.

Biochemical tests (API) for E. coli/Coliforms, S. aureus Salmonella and

etc...

Experience with weighing and dissolution techniques

Created Standard Operating Procedures

Followed all QC procedures for department and Quality Reporting

REFERENCES AVAILABLE UPON REQUEST



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