Quality Assurance
Resume:
Irvington, New Jersey
Phone: 862-***-****
******.*******@*****.***
SUMMARY:
. Degree in Chemistry with over 3 years of GMP experience.
. Maintained good Documentation Practice throughout the validation life
cycle; helped in Implementing Quality Systems that result in
product/system compliance with applicable regulations and policies,
development, and fulfillment of organizational expectations.
. Great understanding of (cGMP) and FDA regulations; followed all company
safety policies and good manufacturing practice; Performed documentation
and batch record review.
. Strong understanding of E U and ISO standards and 21 CFR parts 210,211
EDUCATION:
New Jersey Institute of Technology, Department of Chemistry and
Environmental Sciences
Bachelors Science Degree in Chemistry
PROFESSIONAL EXPERIENCE:
CorePharma LLC- Middlesex, NJ March 2012-
Jan 2013
Validation Specialists
CorePharma, founded in 1998, is a developer, manufacturer and marketer of
high-quality, targeted, generic prescription pharmaceuticals across a
variety of dosage forms and therapeutic categories. They specialize in
difficult-to-develop high value products across a variety of therapeutic
areas and currently produce almost one-half billion tablets and capsules
annually.
. Maintained good Documentation Practice throughout the validation life
cycle.
. Helped in Implementing Quality Systems that result in product/system
compliance with applicable regulations and policies, development, and
fulfillment of organizational expectations.
. Assisted with user testing of systems, developing and maintaining quality
procedures, and ensuring that appropriate documentation was in place.
. Reviewed Equipment validation protocols (IQ/OQ/PQ) for ovens, reactors,
centrifuges, refrigerators,
. Worked in tandem with quality engineering to review/correct executed
protocols, then got them approved; Assisted with test plans for
Functional, Regression and User Acceptance Testing
Ferro, South Plainfield, NJ June 2011-Mar
2012
Validation Specialist
. Assisted with the Validation Production Plan executive summary reports
for completed campaigns.
. Worked as part of a validation documents review team for the QC Move to
validation protocols, Change over protocols, cleaning validations and
equipment-related protocols.
. Maintained good Documentation Practice throughout the validation life
cycle.
. Helped in Implementing Quality Systems that resulted in product/system
compliance with applicable regulations and policies, development, and
fulfillment of organizational expectations.
. Executed and reviewed Equipment validation protocols (IQ/OQ/PQ) for
ovens, reactors, centrifuges, refrigerators; Worked in tandem with
quality engineering to review/correct executed protocols, then got them
approved; Assisted with test plans for Functional, Regression and User
Acceptance Testing
. Assisted with user testing of systems, developing and maintaining quality
procedures, and ensuring that appropriate documentation was in place.
Firmenich- Newark, NJ Jun. 2010-
Jun. 2011
Quality Assurance
. Great understanding of (cGMP) and FDA regulations; followed all company
safety policies and good manufacturing practice; Performed documentation
and batch record review.
. Ensured manufacturing rooms/equipment was cleaned as per SOP and ensured
log books were completed; Conducted offsite audits; worked in tandem with
R&D for quality of products.
. Strong understanding of E U and ISO standards and 21 CFR parts 210,211
. Verified equipment setup as per SOP and MBR.
. Collected in-process samples as well as raw material samples for testing.
. When discrepancies were discovered documented such issues immediately and
took proper steps into the investigation; Reviewed and approved
deviations and investigations.
Actavis Elizabeth LLC- Elizabeth, NJ Nov.
2007-Jun. 2010
Chemical Operator
. Carried out instructions provided by master formulas, standard operating
procedures, safety policies, and company policies; Documented all work on
master formulas and related documents.
. Manufactured quality products utilizing techniques such as granulation,
drying, milling, screening, and blending; operated granulation and
blending equipment such as grals, ovens, mills, and blenders.
. Transported materials via hand jack; Cleaned manufacturing equipment and
manufacturing rooms.
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