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Hanna
Adviento
Hanna C. Adviento
QA Associate IV
B. Braun Medical, Inc.
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76 Greenfield
Irvine
CA
92614
(949) 338-2534
(949) 338-2534
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OBJECTIVE_______________________________________________________________________________ Highly motivated professional with extensive experience in the pharmaceutical industry and recently acquired training in regulatory affairs seeking to transition from quality assurance to regulatory affairs.


EDUCATION_____________________________ _____________
Regulatory Affairs Management Certificate
University of California, Irvine Extension September 2010 – September 2012
Obtained comprehensive training in regulatory affairs, including basic regulatory requirements for medical devices and pharmaceutical products, post-market approval, medical product crisis management and regulatory affairs planning and management.
• Under the guidance of directors and managers of various pharmaceutical and medical device manufacturers prepared hypothetical regulatory affairs submissions necessary for pre- and post-market approval.
• Gained knowledge and insight into the regulatory pathway for changes to labeling, manufacturing process, design, sterilization and packaging.
• Developed plans intended to guide other medical product development professionals through the regulatory approval process.
• Worked with fellow students in preparing pre-IDE submissions and a pre-submission meeting with the FDA.
Bachelor of Science, Psychobiology
University of California, Riverside September 1990 - June 1994

EXPERIENCE____________________________ _____________
QA Associate
Anchen Pharmaceuticals, Inc./Par Pharmaceutical Co. January 2011 – May 2014
Responsible for managing documentation change controls, batch record reviews, and ensuring compliance with the company standards and guidelines.
• Generated SOP to control issuance batch records and management of newly created batch records.
• Issue and review batch records; responsible for maintaining the master batch records and executed batch records.
• Reviewed test methods, validation protocols and reports for accuracy of data, compliance with specifications, and good documentation practice.
• Responsible for verification of approved SOP and other documents, and effectiveness of documents to be released for use.
• Reviewed raw material and finished product testing to ensure compliance with specifications and release for routine manufacturing use.
• Responsible for issuing document control numbers and closing upon meeting all requirements.

QA Stability Specialist/Scientific Affairs Reviewer
Teva Pharmaceutical Industries/Teva Parenteral Medicines, Inc. December 2009– January 2011
March 2007– June 2007
Managed review of test method validations for conformance to pre-defined specifications, compilation of appropriate documentation, and overall validation completeness.
• Reviewed the analytical method validation of HPLC and GC for linearity, robustness and accuracy to ensure conformance to specifications and acceptance criteria.
• Reviewed and approved stability testing data and outcome for assay, impurities, hunter color and physical appearance.
• Reviewed daily QC stability test data to ensure the tests were conducted in accordance with USP and verification of test results.

QA Documentation Specialist
Bio-Rad Laboratories August 2006 – March 2007
Responsible for processing change control requests of revised manufacturing documents and releasing approved documents for training.
• Processed document change controls, incorporated changes as requested, released them for approval and training on operating procedures and batch records.
• Reviewed validation protocols, standard operating procedures, and training packages for GDP and completeness.

QA Specialist
Irvine Analytical Laboratories September 2005 – August 2006
Responsible for documentation review of quality control department.
• Reviewed routine QC chemistry and microbiology test data to ensure conformance to release specifications and test performed in compliance to appropriate SOPs and test procedures.
• Reviewed analytical method protocols to ensure the client requirements have been met and specified.
• Reviewed method validation and stability protocol for samples brought to the laboratory.
• Performed internal audits of QC laboratory for good laboratory practices and compliance to operating procedures.
• Managed and trended deviations and OOS reports to ensure they were thoroughly investigated and documented in compliance with company requirement.

In-Process Control Lead
B. Braun, Inc. September 1995 – September 2005
Served as the Lead for Quality In-Process Control Department and supported all in-process control activities for complex aseptic isolator manufacturing facility.
• Served as the lead of in-process control department to supervise the testing the physical functions of the finished products, released filling & packaging lines for production (line clearance), generate and investigate non-conformance reports, and reviewed batch records to closure and release.
• Executed, reviewed and released manufacturing batch records.
• Executed qualification and validation protocols (IQ, OQ, PQ and Process Validations) for equipment, facilities / utilities, automation, cleaning and process.
• Performed routine analytical testing using UV/VIS Spectroscopy, Flame Photometry, and TOC on in-process and finished product samples.
• Performed investigations on OOS products. Confirmed test results and completed OOS reports in timely manner.
• Performed environmental monitoring for Class 100000 (ISO5) clean rooms and Class 100 (ISO8) clean room hoods to ensure compliance with FDA and company specifications. Performed and analyzed testing for viable and non-viable particulate matter, bioburden, and endotoxin.
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