Training Quality Control
Resume:
General Information:
Phone No./Fax No.: Phone: 252-***-****
E-Mail Address: aboe3s@r.postjobfree.com
Professional Objective:
To seek a responsible position in R&D/QC/Analytical Method Development
laboratory of a reputed organization.
Strengths: Well-versed in theory, operation, troubleshooting and
maintenance of Chromatographic and spectroscopic instruments. Understanding
of cGMP, GLP, FDA, ICH and ISO17025 Guidelines. Highly motivated and result
oriented professional with strong analytical and team building skills.
Ability to manage multiple projects at the same time. Ability to convert
technical skills into practical applications Results oriented, with ability
to efficiently resolve operational problems. Demonstrate flexibility to
accommodate changes in activities. Excellent computer skills in Word, Excel
and PowerPoint also a Quick learner
Professional Qualification & Training:
Varian Dissolution Training (2003) Method Development HPLC Course (2004)
Advance GC Course (2004), Chemstation GCMS (2004), Ion Chromatography
course (2005) Advance Excel Course (2005) Shimadzu HPLC training and
trouble shooting (2005) Empower training (2007), Pittcon (2008), QTOF LCMS
and MSMS training (2010), QQQ training ( 2011), TSRC (2011), GCMS (2012),
Xevo (2012)
Education & Qualifications:
2002 Masters Degree in Organic Chemistry
University of North Carolina at Wilmington, Wilmington,
NC
1999 Masters Degree in Analytical Chemistry
University of Pune, Pune, India
1996 Bachelors Degree in Applied Nutrition, Zoology and
Chemistry
University College for Women, Koti, Hyderabad India
Career History:
04/2012- present Principal Chemist/ Group Leader, HPLC & LCMS, GC and
GCMS
Lancaster Laboratories, Professional Scientific Staffing-
Winston Salem
Responsibilities Include: Same as described below under Sr.
Chemist/Group Leader but for both LCMS and GCMS groups.
. Managing resources, budget planning, client
communication,
. Working in the lab to improve methods to for
efficiency or cost gains or to improve quality
. Working in the lab to develop new methods for
complex tobacco matices involving extensive SPE
procedures both automated and manual
. Validating the methods following ICH guidelines
. Conducting audits, tracking and trending data,
conducting investigation,
. Writing new SOPs, validation protocols, validation
documents, Deviation/investigation reports
. LIMS method templates
. Establishing QC limits for methods
. Implementation of new processes and procedures and
training analysts.
01/11-04/12 Sr. Chemist/ Group Leader, LC & LCMS
Lancaster Laboratories, Professional Scientific
Staffing- Winston Salem
Responsibilities Include:
Supporting work at a client laboratory in Winston
Salem.
Managing technical and personnel aspects of the group
operations.
Acting as a technical resource, trainer and
troubleshooter
Incorporating operational and technical improvements.
Effectively communicating with the group, coaching and
developing direct reports.
Planning and monitoring workflow.
Tracking and Trending data
Managing areas of method development and validation.
Ensuring adherence to highest GxP compliance, safety,
quality and efficiency standards in the laboratory
operations.
Author SOPs, Validation protocols, reports, documents,
exceptions, investigations, CARs and PARs
Identifying compliance GAPs and making sure all written
procedures in place
Participating in audits, conducting OOS and OOT
investigations
Safety audits of the lab
Complete Client satisfaction and exceeding clients
expectations.
10/02 - 01/11 Metrics, Inc., Greenville, North Carolina
08/08 - 01/11 Laboratory Supervisor
Metrics, Inc., Greenville, North Carolina
Responsibilities Include:
Supervise chemists approximately 3-4 (from masters'
level up to PhD) and other laboratory personnel at
various levels.
Direct client contact
Method development for dissolution, HPLC, GC, LCMS and
moisture analysis
Complete ICH Validation
Develop a series of tests to provide quality control
for pharmaceutical raw materials, drug substances, or
dosage forms. Propose specifications for such tests.
Solve problems with methods, instruments, or processes.
Interpret data, draws conclusions, and makes
recommendations based on the data.
Design method validation protocols and conduct complete
validation experiments including force degradation
independently for pharmaceutical raw materials and
dosage forms.
Author analytical procedures, validation documents, and
other portions of regulatory submissions as directed.
Ensure that all work is accurate, precise, properly
documented, and performed within GMP guidelines.
Understand ICH and FDA guidelines
Responsible for Groups Billing and profitability
Teach Industrial chemistry class at ECU every SPRING
07/06 - 08/08 Senior Analytical Chemist
Metrics, Inc., Greenville, North Carolina
Responsibilities Included: Same responsibilities as an
analytical chemist below and additional added
responsibilities as listed
Supervise work flow for employees (approximately 3)
Responsible for training new employees
Writing Documents for IND/NDA Submissions
Interaction with clients on specific projects
10/02 - 06/06 Analytical Chemist
Metrics, Inc., Greenville, North Carolina
Responsibilities Include:
Method Development/ Validation
Writing Reports, Methods, and Validation Documents
Writing Certificate of Analysis
Stability Testing
Investigation of Assay Problems
Instrument Set-up
Installation Qualification/Operational Qualification of
Scientific Instruments
Minor Instrument Maintenance & Repair
Preventive Maintenance and Troubleshooting of
Instrumentation according to the assigned Standard
Operating Procedure
Member of Dissolution Discussion Group
2000 to 2002 Graduate Research Thesis
Department of Chemistry, University of North Carolina
at Wilmington
Responsibilities Included:
Evaluating protease inhibitors, enhancer and bioactive
compounds from zingiberaceae and their structural
elucidalion.
2000 to 2002 Graduate Teaching Assistant
Department of Chemistry, University of North Carolina
at Wilmington
Responsibilities Included:
Laboratory course for 101, 102 and 103
Organization of course syllabi, quizzes and lab
practical, grading of all course work and assignment of
final grades for approximately 24 students per class
01/00 to Lecturer
07/00 St. Georges Grammer School, Abids, Hyderabad, India
Responsibilities Included:
Undergrad lecturer for organic and inorganic chemistry
Organization of course syllabi, quizzes and lab
practical for approximately 35 students in the class
07/99 to Officer 1
01/00 Cheminor Drugs, Balkampet, RRD India
Responsibilities Included:
. Method development/Validation
. Writing reports and validation documents
. Dissolution Assay
. Calibration of glassware
SPECIAL ABILITIES/SKILLS
. NMR
. HPLC (Hitachi, Shimadzu, Agilent, Waters, Dionex)
. IC (conductivity, amperometric detection)
. UV
. IR
. RI
. ELSD
. DISSOLUTION (USP Apparatus I and II)
. GC-FID (Head-space and Direct inject)
. GC/MS
. LC/MS, QTOF, tripleQuad
. HARDNESS
. FRIABILITY
. DISINTEGRATION
. KARL-FISCHER TITRATORS
. RAW MATERIALS TESTING
. TITAN, SPARTAN, FLYER
. CHEMSTATION
. CHROMELEON
. EMPOWER
. MASSHUNTER
. MASSLYNX
* ANALYST
* LIMS
Academic Achievements:
* NCL Scholar (National Chemical Labs, India) 97-99
* Sigma Xi fellowship for research
* UNCW teaching assistant and research scholarship
* Teaching Industrial chemistry class at ECU since 2003
Professional Achievements:
Presentations
* Ninitha, T. and Pamela J Seaton. Isolation and structural determination
of bioactive compounds from Zingiberaceae, Graduate Seminar Series,
University of North Carolina at Wilmington, March 2001.
* Ninitha, T. Radioactive element 131Iodine, Applications. Course CHM 536,
University of North Carolina at Wilmington, February 2001.
* Ninitha, T. and Sandhya Y. Rane. Clinical and Pharmaceutical Analysis,
Graduate Series, University of Pune, India. May 1999
* Ninitha, P. and Jonathan Wilkins. Determination of Ammonia in tobacco
smoke, TSRC 2012
Contact this candidate