Quality Assurance Medical
Resume:
Silva Krikorian
acd9f1@r.postjobfree.com
OBJECTIVE
A Quality Assurance or Document Specialist or Regulatory Affairs position
with responsibility for quality control, medical instrument inspection,
audit preparation, compliance, document control and product improvement.
Seasoned professional with 7 years experience in GMP Manufacturing, Quality
Control, and Regulatory Affairs environment for medical and laser
instrumentation, and experience in aseptic manufacturing quality assurance.
Looking to return to the workforce after raising my family.
SKILLS & QUALIFICATIONS
- Use access database to track all batch records.
- Manage PCR (process change request) database.
- Manage Plateau (training records management) for QA group.
- Verification of manufacturing calculation of critical drug
component.
- Mentoring and training new QA Associate on the routine and
daily reviews.
- Conduct LIMS training and assist users.
- Ability to work individually or in a team.
- Aseptic gown qualified in an aseptic manufacturing facility.
- Knowledge of GMP regulations in aseptic manufacturing
environment.
- HPLC, FTIR, UV spectrophotometer, Particle Size Analyzer
- Knowledge of 21 CFR Part 11, Parts 210 and 211.
- TotalChrom integration software, SQL LIMS, Mfg Pro software
and SAMM (Supplier and material management) database.
- Great attention to detail.
- Excellent writing, spelling and proofreading skills.
- Knowledge of computer systems.
PROFESSIONAL EXPERIENCE
VOLUNTEER, San Jose, CA
- Volunteer for fundraising events for
Homenetmen (non-profit organization) 2009 - present
- Served on the board as an advisor for
the Ladies Society of St. Andrew 2010 -
present
Armenian Church
RELIANT TECHNOLOGIES, Mountain View, CA
Oct. 2008-Dec. 2008
Designer and manufacturer of Medical Lasers.
QA Associate - Responsible for:
- All medical laser system products including hand pieces on
the manufacturing floor, before shipment.
- Conducting in-process and final inspection of laser systems.
- Review of the device history records for all products and
update the tracking database.
- In-process inspection of all tips for medical hand pieces.
- Perform Line Clearance for tips used in medical instruments.
- Maintain the calibration database for all instruments used by
manufacturing, test and QA.
- Set up shipment to vendors for equipment used in all company
departments for calibration.
- Maintain department files and resource materials.
JOHNSON & JOHNSON / ALZA CORPORATION, Palo Alto, CA
2002-2007
Designer and manufacturer of Pharmaceutical Drug Products.
QA Associate - Responsible for:
- Perform daily line audits, aseptic technique audits and
documentation audits.
- Helped support approximately a 100% increase in lots
manufactured and released in 2004 over 2003.
- Perform line clearances in production rooms before production
of a commercial lot.
- Review batch records and release critical components to
manufacturing for use.
- Coordinated testing and shipment of lot clearance samples to
test sites.
- Record and follow up on audit observations and corrections.
- Revise forms and SOP's via Document Change Order process.
- Track status of departures/follow-ups and generate and
distribute departure reports on time.
- Manage recertification and decertification process of the
aseptic manufacturing facility.
- Perform daily review of the BMS (Building Monitoring System)
Report.
- Issue/reissue Master Formula for manufacturing department.
- Responsible for archiving of all batch records.
- Preparation of completed lot release flow charts.
Chemist - Responsible for:
- Expertly used various types of lab equipment.
- Supported other labs by performing formulation development
and research and development samples analysis.
- Tracked raw materials and finished products using LIMS
database.
- Scheduled the raw material calendar.
- Managed attribute verification and certificate verification
of incoming raw materials.
- Coordinated sending samples to contract labs for analysis.
- Approved critical raw materials, while ensuring accuracy of
documentation.
- Participated on safety team and performed monthly inspection
of the lab.
APPLIED BIOSYSTEMS INC., San Jose, CA
2001-2002
Designer and manufacturer of biochemicals automated genetic engineering and
diagnostic research instruments.
Process Chemist
- Responsible for synthesizing synthetic DNA.
DIONEX CORPORATION INC., Sunnyvale, CA
2000-2001
Designer and manufacturer of chromatography and extraction systems for
separating, isolating and identifying the components of chemical mixtures.
Quality Assurance Engineer
- Responsible for evaluation of new products, including running
the equipment under evaluation.
- Critically analyzing the data produced and interacting with
other testers.
BOCCHI LABORATORIES, INC., Walnut, CA
1998-2000
Contract manufacturer of personal care cosmetics, skin, hair care, health
and beauty aid items.
Research & Development Chemist
- Responsible for preparation, control and development of
existing and new batch formulations for new products such as
shampoos, conditioners and others.
- Color match per customer requirements.
- Investigate and diagnose chemical problems in manufacturing
and initiate corrective measures.
- Monitor pilot batches
- Provide support to customers to resolve technical problems.
- Evaluate and improve materials and chemicals introduced by
the vendor.
- Formulate special products for Japanese customers.
EDUCATION
B. S. Medical Technology California State University, Los Angeles,
CA
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