Quality Manager

MARION MASCHERIN

***** ******** *****, *******, ** 77042 • 832-***-**** • abg5tk@r.postjobfree.com

QUALITY ENGINEER

* ***** ********** ** ******** industry

LEGALLY ALLOWED TO WORK IN THE USA (Employment Authorization Card – No Sponsorship

required)

PROFESSIONAL EXPERIENCE

Project Engineer Jan 2014 – Nov 2014

Aker Biomarine manufacturing (Nutraceutical industry, omega 3 oil) (10 months)

• Perform Factory Acceptance Test (FAT):

Check against contractual requirements of 18 equipments/vendors,

Detect 21% non conformities,

Negotiate with vendor delivery time and pricing while ensuring completeness

and enhancement of equipment: 95% of equipment delivered with no impact on

construction schedule.

• Carry out Site Acceptance Test (SAT):

Create and write of 72 tests procedures to ensure that equipment are working to

specification,

Define quality and process standards,

Commissioning with vendors on site: achievement of 100% SAT tests and

resolution of 90% non quality items before starting production.

• Lead Hazard analysis and critical control points (HACCP):

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Identify 6 critical control points in the entire process,

Establish critical limits for each critical control point,

Establish critical control point monitoring requirements: written all procedures

and training of 100% production staff.

• Prepare NSF Audit (Public Health and Safety Organization):

Develop Project Quality Plan to ensure all customer requirements are

understood.

MARION MASCHERIN

10440 Deerwood Drive, Houston, TX 77042 • 832-***-**** • abg5tk@r.postjobfree.com

Quality Manager Sept 2011 – Sept 2013

IBA molecular (Radiopharmaceutical industry, sterile drug product /aseptic processing) (2 years)

• Quality Control responsible:

Approve daily production market release: 1M€/month, 3 batches/day,

conformity of 100% batches released in 2 years (almost 1,300 batches),

Implement and qualify a new quality control method to improve from 30min to

10min the analysis time,

Review the specification according the trends monitoring,

Design new preventive maintenance plan for the Quality Control equipment.

• Develop the Quality control plan:

Introduce new internal QA audits on a weekly base,

Design the new Incident Report Form to eliminate the incident root cause

(Corrective and Preventive Action): recurrent incidents have been dropped by

8.

• Lead external audits:

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Passed all the yearly French Health and Nuclear Safety Regulatory Authorities

audit: no critical comment.

• Commissioning of new production line for a hospital (10M€ over 2 yrs).

Produce Project Quality Plan to ensure all customer requirements are

understood,

Define and buy all the Quality Control equipment: delivery on time,

qualification on time with no critical items before starting production,

1st commercial production successfully released on July, 2013.

MARION MASCHERIN

10440 Deerwood Drive, Houston, TX 77042 • 832-***-**** • abg5tk@r.postjobfree.com

Project Manager Sept 2010 – Sept 2011

GlaxoSmithKline (Pharmaceutical industry, sterile drug product / aseptic processing) (1 year)

• Design the new QA management system for aseptic processing lines (20 people).

Train the lean implementation team using "brainstorming", "kanban", "takt

time", "5S" methods.

Introduce new standard practices to reach quality objectives (below 5% non

conformity).

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Improve by "Lesson Learned" the productivity of one production line from

30% to 45% of its capacity.

Production Manager Sept 2008 – Sept

2010

GlaxoSmithKline (Pharmaceutical industry, sterile drug product / aseptic processing) (2 years)

• Production and QA Management (Team of 50).

Ensuring that drugs are produced on time and budget (300 M€/year).

Ensuring good product quality for market release (less than 7% non

conformity).

Monitoring product standards and implementing Quality Plan (internal

audits).

Managing Deviation Notices, Corrective and Preventive Actions, and

Change Control.

EDUCATION, LANGUAGES & ACCREDITATIONS

Education

Master of Science (MSc), Process Engineering (2008).

ENSIC: Chemical Process Engineering University of Nancy, France.

Master of Science (MSc), Pharmacy (2008).

University of Lorraine (Pharmacy), France.

Languages

Fluent in written and spoken English and French.

Accreditations

Certificate of Radioprotection, Industrial field (2011) CEA (French regulatory Authority

for Atomic Energy).

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