Quality Assurance Management

ANNE M. ARMSTRONG

**** ********** ***** ** **

Caledonia, MI 49316

Home:616-***-**** Cell: 616-***-****

acbdv5@r.postjobfree.com

PROFESSIONAL EXPERTISE:

. 15 years in the area of pharmaceutical Quality Assurance

. 20+ years in the area of Quality Control/Assurance at the

management level

. Designed and implemented a Quality Documentation System Program

for two GMP start-up operations

. Key member of teams charged with new product introduction and

product and assay transfers

. Background in ISO 9001 and CE Marking

. Experienced in the design of pharmaceutical and food quality

systems to meet federal (FDA, DEA, USDA, EMA) regulations

. Implemented Total Quality Management philosophy through the team

concept

. Implemented Safe Quality Food (SQF) Level III program in less

than six months

. SQF certified Practitioner

. Experienced in CAPA investigations and formal report preparation

. Experienced with equipment qualifications and water system

validation

. Skilled in the use of Microsoft Excel, Word, PowerPoint, Visio,

and various Company-specific inventory and quality control

systems

. Audited and trained for pharmaceutical, medical device, cosmetic

and food compliance

. Responsible for inspection preparation and management during on-

site regulatory authority inspections from local (FDA, DEA, EMA)

agencies

. Designed GMP, Defect Awareness and Safety training programs

. Background in the foreign import and export of finished products

. Genuine personal charisma, along with technical expertise and

strong business acumen

1 EMPLOYMENT HISTORY:

. Sixarp, LLC-Praxis (formerly Macatawa Holdings LLC-Praxis and

Praxis Packaging)

Vice President of Quality

September 2006 - October 2013

> Responsible for a three shift tablet filling and

pharmaceutical/OTC/medical device/cosmetic/food contract

packaging operation at two locations - Michigan and Ohio.

> Accompanied the FDA, DEA, Dept of Agriculture and third

party auditors during regulatory inspections.

> Worked with a team on the installation and validation of a

tablet filling line.

> Member of the senior management team which was responsible

for budget management, organizational chart decisions,

review of KPIs and annual business planning.

. Surefil LLC

Director of Quality Assurance and Regulatory Affairs

October 2005 - August 2006

> Worked with a team of colleagues to source and set up the

building, equipment, and employees.

> Implemented the Quality systems which included document

control, change control management, CAPA investigations,

record retention, calibration and preventative maintenance,

training, and internal/external audits.

> Worked with the team involved with the installation and

validation of the blending, holding, and filling equipment

as well as the purified water system.

. Pfizer Corporation

Pharmacy Operations - Packaging Coordinator

May 2004 - October 2005

> Responsible for the design of clinical packaging protocols

in Clinicopia.

> Partnered with a team of Supply Chain Coordinators,

Packaging Technicians, Quality Assurance, and Materials

Management to meet clinical requirements.

> Ensured that the activities involved in the clinical

supplies packaging operation such as drug receipt,

preparation of documentation, label design and printing, QA

preapproval, filling, labeling, testing and release were

completed within the required timeframe.

US Area Logistics Services - Quality Assurance Professional

September 2002 - May 2004

> Responsible for the quality management and GMP/Regulatory

compliance of the Kalamazoo Logistics Center in the

distribution of pharmaceuticals and medical devices to the

US market.

> Responsible for the response to both internal and external

customer complaints including the appropriate

investigations and preventive/corrective activities.

Global External Supply Quality Assurance- Quality Assurance

Professional

June 2000- September 2002

> Corporate Quality Assurance role conducting quality and

compliance assessments of domestic-based Contract

Manufacturing Organizations, responsibilities included

ensuring CMOs meet Pfizer quality standards, establishing

and maintaining Quality Agreements, batch release, tech

transfers, annual product reviews, validation and

continuous improvement and change control in a global

regulatory environment.

. Praxis Packaging, Inc. (formerly Fleet Contract Packaging, Inc.)

Quality Assurance Manager

August 1998-June 2000

> Responsible for the quality and GMP-compliance of a three-

shift operation in the secondary packaging of

pharmaceuticals, over-the-counter drugs, and primary and

secondary packaging of food products.

> Key member of the team responsible for the introduction of

primary packaging of a food product for a major

manufacturer.

. Inrad, Inc.

Director of Quality Assurance/Regulatory Affairs

July 1997-August 1998

> Responsible for the quality, GMP and regulatory compliance of

a one-shift operation in the production of Class II medical

devices.

> Responsible for all aspects of Quality Assurance and

Regulatory Affairs including inspections, testing, training,

specification development, validation and supplier quality

auditing.

. Ranir/DCP Corporation

Director of Quality Assurance

June 1990-July 1997

> Responsible for the quality and regulatory compliance of a

three-shift operation in the production of Class I medical

devices.

> Responsible for the implementation, training and upkeep of

machine vision systems for toothbrush equipment.

1 EDUCATION:

Bachelor of Science - Michigan State University

Post graduate classes in Purchasing, Microbiology, Human

Relations, Management, Business Management, Data Processing,

Quality Techniques and Tablet Technology.

1

REFERENCES

. Available upon request

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