Quality Control Assurance
Resume:
Objective
To find a rewarding position that would enable me to explore and continue
to grow on furthering my understanding and knowledge of the factors,
research, fondation and resourses in a company such as pharmaceutical
companies or in any fields.
Profile
o Well-qualified and technically-proficient Scientist with approximately
nine years laboratory experience and excellent academic qualifications
o Ability to plan and oversee projects from concept to successful
conclusion.
o Self-motivated and compassionate team player with strong interpersonal
and communication skills
o Accustomed to handling sensitive, confidential records.
o Possess the ability to interact with multiple internal and external
parties
o Expertise in lab and field research, data collection/analysis and
project management.
o Extensive experience working with cross-functional scientific and
research teams.
o Excellent organizational and problem solving skills
o Proficiency in computer and software skills
Education
New York State University of Binghamton
B.S. Chemistry GPA:4.0 Summa Cum Laude
2004
Minor in Mathematics
Skills Summary
Fourier transform Gas Chromatography Plasmid purification
infrared (FTIR) (GC) Preparation of biochemical
spectroscopy Restriction solution
Ultraviolet Spectroscopy Digestion enzyme Thin layer chromatography
(UV) Knowlegdeable in FDA (TLC)
Titration guideline
High-Performance Liquid
Chromatography (HPLC)
Professional Experience
SUPERVISOR OF R&D / HEAD MANAGER OF QC DEPARMENT
INNOVATIVE COSMETIC CONCEPTS, LLC _ Clifton, NJ 12/10-1/13
Managed all functions of two departments, which included: wiriting SOP's,
QA, safety/ stability/ analytical testing of new
Products, preparation of necessary documentation for release of bulk to
production, launch dates. Evaulated novel raw
materials, natural ingredients for the creation, development and
formulation of new concepts for nails polished strips from
inception through completion. Effectively worked in tight contact with
all internal departments and outside vendors to finalize formulas for
scale up and first production.
o Developed water based nail polish comparable with existing solvent
based nail polish in properties like color, gloss, coverage, flow,
adhesion and water resistance
o Participated in development of daily nutritional supplement with
biotin to improve nail growth
o Lead an evaluation of new raw materials, pigments/ colorant for nail
polishes, and various additives, emulsification system to invent new
properties, and develop formulas for personal care products: nail
polishes, treatments
o Provided analytical testing by using instruments such as HPLC, GC, MS,
FTIR and wet chemistry
o Writing and reviewing reliability testing protocols and reports as
required. Train new reliability technologists when required.
o Interpreted clinical date for all new products, write concise reports,
developed innvative claims
o Perform additional research and development study protocols and other
duties as required by customers.
o Evaluated finished products for chemical and physical properties
according specification in QC/QA
o Proficient in Development and validation of procedures for analytical
testing, writing specifications, SOP's and preparation of required
technical documentation, validation reports
o Responsible to keep accurate training records, plan and direct
training sessions to improve efficiency of technical staff.
o Identify areas to improve department acitivities through additional
training, updating Standard Operating Procedures (SOPs) and forms to
keep them current to ensure all documentation reflects the state of
compliance and control required the QA and RA
o Direct special projects independently and provide quality planning to
ensure compliance
o Responsible to provide inventigation reports including root cause and
corrective actions and manufacturing assessment for non-conforming
materials/ deviations/ OOSs.
o Responsible for coordinating associated investigation reports for CAPA
in a timely manner.
o Responsible to execute process / products/ equipment IQ/OQ/ PQ
validation protols, document results, prepare and publish reports
o Responsible to maintain in-process testing data base and perform
relevant statistical analysis including trend analysis
o Responsible for auditing, reviewing and approving data generated in
formulation lab for in-process testing and instrument calibration/
verification for accuracy and cGMP compliance.
LABORATORY QUALITY SUPERVISOR
INSTRUMENTATION LABORATORY- ORANGEBURG, NY
10/07-11/10
Spearheaded daily operations management for the Quality Control Lab;
established project priorities and managed testing and disposition of new
components in an expedient, compliant manner. Supervised a group of
analysts working in-process monitoring samples, manufactured isolated
intermediates, finished projects and technical operations regulatory
support projects.
o Coordinated the evaluation, planning, implementation and
qualification/ validation of new instruments for the lab and ensured
that validated/ qualified/ calibrated laboratory systems were
maintained in a cGMP compliant state throughout their life cycle.
o Planned and provided Analytical Chemistry support (i.e. method
modification and validation, testing, protocol and report writing, and
reviewed of regulatory documents) for intermediates and finished
products.
o Verified compendia test methods.. Modified, reviewed, and/or approved:
project plans, Standard Operating Procedures, capital appropriation
requests, Change Control Requests, preventive maintenance work
schedules, maintenance work orders, investigation protocols and
reports, validation protocols, and validation report.
o Maintain laboratory facilities, equipment, raw materials, reagents,
product and competitive product inventory, and MSD files required for
product formulation, evaluation and testing.
o Design experimental studies and conduct statistical evaluations of
results
o Collect data needed for product regristration with federal, state, and
other regulatory agencies.
o Interpret test results and investigations.
o Conduct chemical and physical evaluations (e.g. titrations, viscosity,
pH, stability, compatibility, phase behavior, surface tension) on
various formula applications.
o A strong understanding of the product development process from concept
ideation through to launch.
o Develop and maintain a database of registration activities and project
status.
o Proactively evaluated and implemented process changes and
improvements.
SCIENTIST, QUALITY CONTROL
NICE PAK - ORANGEBURG, NY
10/04-10/ 07
Worked closely with the Research and Development laboratories and Quality
Unit groups to ensure that methods development/optimization, validation
and verification, software validation and ensuing technology transfer
were executed in a timely manner. Modified and validated chromatographic
methods for assay of pharmaceutical compoments, drug products containers,
and closures. Evaluated and acquired new analytical technologies such as
laboratory instruments, computer hardware and software for the
department. Supported and performed launching of new products.
o Ensured that analysts appropriately trained on cGMPs, SOPs and safety
policies. Coordinated review of any changes or updates of compendia
procedures by Quality Control laboratories, Quality Assurance, and
other appropriate quality department.
o Performed and coordinated analytical method transfer, data review,
creation and revision of SOPs as well as routine release, stability
testing, and related reports.
o Oversaw and performed analytical work in support of manufacturing
equipement cleaning validation.
o Evaluated OOS investigation and ensured that appropriate corrective
actions were followed as stipulated in the FDA and cGMP guidelines and
company policy.
o Participated internal and FDA laboratory inspections.
Awards
Employee of the Year, Innovative Cosmetic Concepts, LLC
12/2012
Achievement Award, Instrumentation Laboratory
12/2009
Employee of the Month, Nice Pak
09/2006
Student Award, the American Institute of Chemists Foundation 2004
05/2004
References available upon request[pic]
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