Garima Sharma

** ****** ***** *****. ********, MD 21227 410-***-**** aczcsp@r.postjobfree.com

Professional Skills Summary

• 5 yrs of experience working in Quality Control and production environments

Working knowledge/familiar with various lab equipments – pH/conductivity meter, Endosafe PTS, Light microscope, Milliflex pump, TOC reader, Analytical balance, SAS viable sampler, Met One and Climet particle counters, Osmometer, Spectrophotometer and autoclave

Competent using LIMS, MODA, Trackwise, Master Control, Documentum and HACH portable software

Proficient working with quality management systems including change controls, batch records, deviations, CAPA and documentation management.

Gown Certified, knowledge of cGMP/GLP procedures, aseptic techniques and industry standards

Write, Review and approve standard operating procedures, memos, investigation reports and other GMP documentation

Performs QC internal audit and write reports

Actively participates in the development, review and approval of equipment validation/qualifications (IQ, OQ and PQ)

Good interpersonal, communication and organizational skills

Proficient using MS-word, MS-excel and PowerPoint

Work Experience

MacroGenics, Inc. Rockville, MD April 2015-Present

QC Analyst

Supports Manufacturing department

• Performs static and dynamic Environmental Monitoring in GMP manufacturing area (ISO-5,

ISO-7 and ISO-8 classrooms) using LIMS system.

• Performs routine water and compressed air/gas sampling collection of the GMP

Manufacturing area

• Perform plate enumeration, Isolate and identify microorganisms recovered from EM samples

using gram staining and other techniques

• Participates in validation and calibration of EM equipments and data trending as needed

• Participate in Initial and performance qualification of cleanroom core under static and

dynamic conditions

Responsible for Analytical testing

• Measure pH, conductivity and Osmolality for stability and in-process samples

•Responsible for bioburden, TOC and endotoxin testing for EM samples, column cleaning

samples, water and in-process samples

•Conduct routine and non-routine analyses of raw materials and stability/finished in process

samples according to standard operating procedures as needed

• Perform swab testing during column cleaning used for downstream processing

• Write, report and evaluate test results

Perform QC Audit, manage EM related investigations, deviations and change control within Trackwise

• Conducts EM related investigations; initiate and route EME (Environmental monitoring

excursion) notification forms and complete investigation reports

• Perform root cause analysis

• Develop Corrective and Preventive actions (CAPAs) to offset root cause analysis

• Monitor, drive and complete deviation records

• Open EM related change control records, monitor and close them in a timely manner

• Perform monthly QC internal audit and write audit report with observations and findings

Write, review and approve GMP documentation

• Review and approve EM related protocols, formbooks, logbooks and EM data in LIMS.

• Perform Data review and trending to ensure integrity and adherence to standard operating

procedures and cGMPs

• Review data obtained for compliance to specifications, and report abnormalities

• Create and revise standard operating procedures and forms

Miscellaneous duties within QC department

• Performs Equipment/instrument standardization and calibration, as required for testing per

SOP’s

• Serve as one of the interviewers in the panel to interview new candidates for position within

QC department

• Interacts on daily basis with Quality assurance and manufacturing department to discuss work

Processes and address any GMP issues.

• Train new analysts on EM, QC testing and cGMP/GLP procedures

•Ship samples and monitor test results produced by contract testing laboratories

•Maintained the lab: Order Lab supplies, equipment cleaning, inventory and restocking

Renaissance LLC. (DPT Laboratories), Lakewood, NJ July 2013-April 2015

Microbiologist

Supported Manufacturing department

• Performed static and dynamic environmental monitoring in grade A/B/C clean rooms using

MODA-Evaluates, reports and records data

• Responsible for timely reconciliation and incubation of media plates and reviewing related

paperwork

•Responsible for plate enumeration and media read during media fill operations

• Responsible for water and gas sampling in cleanroom areas

• Prepared media and reagents required for microbiological analysis

• Participated in media qualifications for new products and validation of new equipments used

in EM

Responsible for Analytical testing

• Performed bioburden and endotoxin testing on water and in-process samples

• Wrote and evaluated testing results

Wrote, reviewed and approved GMP documentation

• Wrote and revised Standard operating procedures, forms, protocols and other controlled

Documents using documentum software

• Reviewed documentation for compliance to GMP and test methods.

Managed EM related investigations, deviations and change control within Trackwise system

• Initiated proper documentation upon discovery of deviations and out-of-specification results,

completes report write-up for deviations and out-of-specification results.

• Performed root cause analysis

• Approved all EM related specifications in QIS

• Developed and executed corrective and preventive actions

• Monitored and completed deviation records

• Performed assessments for change controls related to Microbiology specifications

Miscellaneous duties within Microbiology department

• Performed special projects as assigned including protocol generation, testing, delegation of

tasks, compiling and trending of data, and report generation

•Maintained intra and interdepartmental communication to support company goals.

•Trained new analysts on EM, QC testing and cGMP/GLP procedures

• Performed lab area monitoring, equipment calibration and maintenance,

temperatures/humidity monitoring for testing areas, and performed sterilization procedures.

• Initiated, documented, and performed microbiological analysis on received test samples

(including raw materials, bulk, final product, stability, water) as per USP, in-house, or customer

methods. Evaluates, records, and reports data.

•Maintained the lab: Order Lab supplies, equipment cleaning, inventory and restocking

Renaissance LLC. (DPT Laboratories), Lakewood, NJ June 2012-July 2013

Gown qualified Aseptic Production Technician

Performed Aseptic filling operations

•Operated aseptic manufacturing equipments involved with preparation, manufacture and

inspection of sterile products in class A/B/C clean rooms

•Produced requirements by operating and monitoring equipments; observing varying

conditions; adjusting equipment controls; calculating concentrations, dilutions and yields;

adhering to aseptic filtering and filing procedures

•Responsible for daily manufacturing tasks following SOPs and batch record instructions

•Maintained safe and clean work environment by following current good manufacturing

practices, Standard operating procedures; complying with legal regulations; monitoring

environment

Reviewed Batch Records

• Responsible for reviewing batch records for both commercial and development

Operations

• Revise specifications in the batch record as per the needs of clients.

Inspection, packaging and Reconciliation of finished products

• Performed Reconciliation of all products and packaging components under strict adherence to cGMP and OSHA regulations.

• Ensured the quality and integrity of products produced is in compliance with cGMP and safety requirements

•Monitored and audited work processes to ensure compliance and completion of targets

Reviewed GMP documentation

• Responsible for reviewing, documenting and recording all data as per SOPs and GMP/cGMP requirements.

Education Background

University of Maryland, Baltimore, MD

M.S in Regulatory Science, Pharmaceutical Sciences, School of Pharmacy (GPA 4.0) Expected date: May 2017

Related Coursework:

• Drug, Biologic and Device Regulation •Drug and Biologics development • Phase IV Research

• Pharmacovigilance •Clinical Research • Chemistry, manufacturing and Controls

Rutgers University, New Brunswick, NJ

Bachelor’s in Biological Sciences with Psychology minor, School of Arts and Sciences, May 2012.

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