Quality Assurance System

HANNAH DANG

Bridgewater NJ *****

908-***-****, **********@*****.***

Self-motivated and detail-oriented leader with twenty years of experience within the Medical Device, Biotechnology and Pharmaceutical industries. Possess substantial knowledge of cGMPs, cGTPs, Quality System Regulations, ISO regulations, AATB requirements, and current industry standards. Demonstrated leadership in building high-performance teams that consistently deliver deadline-driven and high-profile projects to meet company objectives.

Experiences:

FlexBiosys, A Repligen Company– Branchburg, NJ September 2020 – Present

Manufacturer of single use bioprocess containers, tubing assemblies and single use fluid path systems for biopharmaceutical customers.

Quality Assurance Manager

Successfully implemented and maintain an effective Quality Management System compliant with ISO 13485 & 9001.

Facilitate and maintain a risk-based quality system to support cGMP and GDP.

Reduce non-conformance incidents by 20% through proactive quality initiatives.

Conduct internal audits and host external audit programs.

Oversee the customer complaint process.

Provide subject matter support for quality investigation, root cause analysis, CAPA and report writing.

Create and approve quality related procedures.

Review and release batch records.

Manage quality-related training program.

Collaborate with management to propose and complete improvement activities.

Oversee site sterilization validation programs.

Manage the site cleanroom certification.

AbbVie/LifeCell – Branchburg, NJ August 2014 – September 2020

Manufacturer of tissue matrix, AlloDerm (humane tissue) & Strattice (pig tissue), biologically based products that expedite the body’s ability to fully heal.

Sr. Supplier Quality Engineer/Team lead

Oversaw 217 suppliers, including contract laboratories, contract manufacturers, human tissue bank, and sterilizers.

Collaborating with suppliers to resolve manufacturing, quality, technical, and supply issues.

Facilitating overall quality improvements.

Conducting supplier qualification, routine, and for-cause audits

Assessing performance risk and impacts related to internal change control, supplier change control, supplier nonconformance (SCAR), and CAPA.

Reviewing and approving quality documents, including material specifications and procedures.

Leading and supporting teams in investigating quality issues (failure investigations) related to complaints, non-conforming products, CAPA and SCAR.

Creating, negotiating and maintaining critical supplier Quality Agreements.

Collaborating with cross-functional teams to identify potential areas of process variability, addressing root causes, and implementing improvements.

Leading, training and coaching junior team members in conducting audits, writing non-conformance reports, CAPAs and change control.

Integra LifeScience – Plainsboro, NJ November 2013 – August 2014

Manufacturer of orthopedic and reconstructive medical devices (class III)

Sr. Supplier Quality Engineer

Lead and managed supplier performance program included SCAR and Supplier Change Notification. Performance impact assessment.

Perform investigation on supplier related nonconformance.

Identify improvement projects and manage cross functional implementation to improve performance of key components and suppliers.

Conduct supplier audit.

St. Jude Medical – NMD Division, Hackettstown, NJ October 2009- November 2012

Manufacturer of IPGs and related external control modules for Pain Control (Class III Medical Devices)

Quality Assurance Engineer/Supplier Auditor

Managed internal audit program: developed, executed, and then followed up with the verification of the correction effective (CAPA) to assure the internal audit-quality subsystem compliance with ISO, GMP and Affiliate requirements.

Managed 132 suppliers. Conducted supplier onsite audit for critical suppliers.

Evaluated and determine the internal requirements for approval of all specific supplier change requests (SCRs)

Participated in written policies and procedures for Supplier Qualification. Work with suppliers to improve their quality performance and reduce costs.

Conducted nonconformance material investigation, problem solving and root cause analysis: CAPA, SCAR.

Conducted data analysis for acceptance and reject rate at Receiving Inspection using statistical techniques.

Conducted Material Review Board (MRB).

Established critical and secondary quality metrics, track and trend quality data

Participated and supported TUV, FDA and 3rd party audits. SME for Internal Auditing Program and Supplier Qualification Program.

Reviewed and approved Engineering Change Notification (ECN) that included manufacturing work instructions, procedures, SOPs, PFMEAs, FMEA and control plans.

Siemens USA HealthCare - Customer Solution Group, Malvern, PA January 2008 – June 2009

Healthcare Services, Medical Imaging and Laboratory Diagnostics (Class I Medical Devices)

Quality Assurance Engineer - Level III

Lead and participate in supplier development projects and continuous improvement activities focusing on supplier quality.

Ensured supplier requirements are scoped properly to compliance with all requirement specifications.

Cordis Corporation, a Johnson & Johnson Company, Warren, NJ. July 2002-December 2007

Development and Research Cypher Stent/Drug Coated Stent (Class III Medical Devices.

Quality Assurance Engineer Level II: August 2007 – December 2007

Prepared Department Management Reviews. Implementation of comprehensive metrics reporting and trend evaluation to support Quality System Effectiveness assessments.

Participated and supported internal audit program.

Monitored internal audit corrections within SmartSolve.

Supplier Quality Assurance (SQA) Engineer Level II: March 2005- August 2007

Conducted data analysis to support Supplier Metrics/scorecard system.

Supported Supplier Development group in monitoring the impact of target supplier toward Receiving Inspection (RI), Non-Conformance Issues (NCI) and other defect.

Reduced the cost of audit expend from onsite audit to desktop audit by using ISO 17052 for Calibration Services providers. The project saved 25K.

QA Engineer Level II: March 2003 – March 2005

Supported failure/complaint investigation within in Quality Assurance Laboratory

Held a responsive role for troubleshooting and performance qualification in QA Lab.

Participated in method transfers for test methods in QA Lab.

Initiated and supported ongoing process improvement within area of responsibility.

QA Engineer Level I: July 2002 – March 2003

Trained employees in laboratory procedures including the Stability Indicating Method Assay and Impurity (HPLC), and Elution method (USP apparatus 4 & 7).

Analyzed stability data for method improvement.

Performed routine analysis: Rapamycin and its impurities/degradation products in CypherTM Sirolimus-eluting Stents by reversed-phase HPLC, and Elution Testing on both in-process and final products.

Education:

Rutgers University, School of Engineering, New Brunswick, NJ

Bachelor of Science in Chemical Engineering

Certified Auditor/Lead Auditor for ISO 13485

Certified Part 820_Quality System Requirement for Industry & Practice

Certified Tissue Bank Specialist- CTBS by AATB

Certified Internal Auditor Training to the Medical Device Regulation (EU-MDR 2017/745)

Awards:

Standard of Leadership Award, Johnson&Johnson.

Patent of new product and formulation for transparent soap bar at Colgate-Palmolive.

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