Quality Assurance Manufacturing

JENIFFER MA

**** ******** ***** *** ****, CA ****1

Email: ***********@*****.*** Mobile: 408-***-****

SUMMARY:

> Experience in Aseptic Processing and proficiency in Aseptic Gowning

qualifications.

> Cross trained for multiple standard operating procedures (SOP) and

best practices in clinical manufacturing (including Validation,

Engineering, Quality and Safety).

> Extensive experience in the manufacture of products for Commercial,

Clinical and R&D, with strict adherence to compliance requirements

including cGMP regulations.

> Skilled at operating automated coating machine, assembly machine, and

HMI (Human Machine Interface), and manufacturing equipment including

Centrifuge, Tip Dispense, Microscope, Caliper, Optical RAM, Heat Sealer,

Forming Press, Oven, Sonicator, Balance, and XYZ Linear Coating System.

> Worked closely with engineering teams to conduct electrical testing,

provide troubleshooting solutions and documentation from the component

to system level, updating SOP.

> Pro-active quick learning individual that is efficient while detail-

oriented and enjoy working in team-based, multi-tasking environments.

> Over 10+ years experience in quality testing, auditing, and aligning

Optic helmets using intricate tools for the U.S. Military while

following stringent procedural, safety and documentation regulations

EXPERIENCE:

Process Development Technician Apr-2012 - Dec-

2013

Zosano Pharma, Fremont, CA

> Responsible for manufacturing operations including lot initiation,

daily startup, daily production, and lot closeout to ensure

compliance with cGMP regulations and company policies.

> Extensive experience in operating automated coating machine, assembly

machines, and HMI (Human Machine Interface), and manufacturing equipment

including centrifuge, pipette dispenser, oven, RAM Optical inspection and

measurement system, sonicators, balance, rotator, and autoclave.

> Responsible for the development and scale up of production Phase 2 & 3

clinical supplies in an aseptic environment.

> Worked closely with team members to support clinical manufacturing

processes and experiments, including sensitive equipment setup

coating, assembly reservoir, forming, sealing, pouching, packaging

and labeling products.

> PTH Micro-projection Drug Delivery system development.

> Responsible for troubleshooting equipment malfunction(s) and providing

solution recommendations to Process Engineering Group and/or Management.

> Complete and review production records to ensure cGMP documentation

practices are met.

> Provide daily detailed summary reports/next steps to

Supervisor/Management and hand over teams.

> Ensure a safe work environment is maintained at all times by managing

aspects of equipment, sanitation, inventory and facilities with

management.

> Identify and support the implementation of process efficiencies and

areas for improvement.

> Setup of pilot plant equipment and over saw day to day pilot plant

activities.

> Skilled in coating, forming and packaging.

> Responsible to perform training of new Manufacturing personnel in

different process nodes.

> Support Material Management with their daily activities when needed.

Manufacturing Technician Oct-2010 -

Apr-2012

CoaguSense Inc., Fremont, CA

> Replaced defective Electrical /Mechanical components utilizing most

hand tools, wiring, and schematics/diagrams.

> Supported preparation: processing of plasma, reagent formulation and

testing, including equipment set-up, operation, reviewed batch record

documentation and revised SOPs.

> Proficient in operating of a MultiAxis Table used for setup for XYZ

Linear Coating System and Control/PT Strips for Coagulation Systems as

well as Yamato ovens used for drying the strips and Band Sealer and

packaging.

> Utilized caliper to perform Q.C. inspection of incoming raw material

based on Material Specification.

> Successfully managed barcode labeling and packaging of Final product

to meet mandated shipping timelines.

> Assembling, disassembling, troubleshooting and testing of Coagulation

Monitoring System.

Manufacturing Electrical technician Aug-1987 -

Jan-2010

Rockwell Collins Inc., San Jose, CA

> Improved reliability, quality and manufacturing in low-yield products

to reduce cost.

> Highly effective in meeting deadlines, proficient in handling

multitude of tasks under pressure, and responding with speed and accuracy

in a highly productive manufacturing setting.

> Worked closely with software engineers in redlining procedures and

also assisted in new test setup, provided quality support to operations in

a timely and efficient manner.

> Tested, aligned and troubleshoot Military Display System and Head-up

Helmet Display, Cathode Ray Tube and Optic assembly.

> Troubleshooting root caused analysis of failed units by using

Voltmeter and Oscilloscope and schematics.

> Assembly rework performs repairs and modifications on a variety of

complex electronic equipment utilizing micro-soldering. Performed Q.A. and

final inspection on production unit.

> Perform Quality Assurance inspection per ISO-9001.

EDUCATION/SKILLS:

> A.A.S Degree (Association Applied Science) Electronic/Computer

Technology - 1999

Heald College School of Technology, Milpitas, CA

> Certificate in Soldering - 2010

Rockwell Collins Corp Training, San Jose, CA

> Microsoft Word and Microsoft Excel proficient

> Fremont High School CA - 1983

Jeniffer Ma ***********@*****.***

408-***-**** Page 2

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