Quality Control

Qualifications:

-Bachelor's degree in chemistry.

-Internet research and MS Office software experience.

-More than 5 years in FDA-regulated manufacturing and research, including

Quality Control roles.

-Proven ability to work successfully as a team member and independently.

-Demonstrated background of problem solving and organization with attention

to detail.

-Excellent communication skills, both interpersonal and written.

Education:

Temple University Arcadia University

Philadelphia, Pa Glenside, Pa

Major - Chemistry Bachelor's in Chemistry

08/2000-05/2002 Graduated May 2005

Work Experience:

Technical Writer, Quality Manager and Development Chemist at New Jersey

Feed Lab.

07/2012 - Present: Successfully developed new analytical tests, quality

document creation, tracking and management. Identification, investigation

and resolution of quality issues. Identified and solved analytical

deviations through statistical analysis of quality data and experimental

results, collaboration and proficiency studies. CAPPA, documentation review

and systems design, successful team collaboration to introduce a quality

management system and GMP/GLP procedures to current practices.

Technical Writer for U.S. Navy, through Vision Point Systems.

02/2012-07/2012: Attained high-level government security clearance to

perform technical writing, including schematics of ships, SOPs for

corrosion inspection, reporting and corrective actions, laboratory

procedures and deliverable reports. Statistical and data analysis of

inspection and laboratory results. Use of government databases and software

programs.

QC Document Specialist at Roche Diagnostics

08/2011-02/2012: Technical writing, editing, data analysis and problem

solving for SAP and LIMS data systems.

Chemist at Merck through On-Board Services.

08/2010 - 08/2011: Protein purification, research and development of siRNA

therapy.

Use of ELN, development of purification processes for breakthrough

therapies and vaccines. Literature research, troubleshooting, method

development and process scale-up.

Competitive Analyst at Brock, Inc.

12/15/2009-08/2010: Competitive analysis for healthcare and pharmaceutical

market research. Statistical analysis and visual presentation of

healthcare data.

QC Specialist at GE Water & Process Technologies

01/2008 - 12/15/2009: LEAN six-sigma training, ISO-9001 and GMP auditing

of manufacturing plants, including development of FDA and NRC products.

HPLC/GC analysis, troubleshooting and method development, technical

writing, QC analysis and establishment of specifications, including

communication with suppliers and contractors. Coordination and

interpretation of analysis from various departments, process scale-up and

development, direction of technicians, corrective action implementation,

deviating process investigations, member of VPP Environmental Health and

Safety Group, Fire Captain, ergonomics committee member.

QC Chemist at GE Water & Process Technologies

08/2007 - 01/2008: QC testing for specialty polymers and raw materials,

industrial dyes and inks. SOP and report writing, HPLC/GC analysis, Quality

Response Group (QRG) emergency response member, member of VPP Environmental

Health and Safety group, incident investigation and resolution (CAPPA),

coordination of global testing and material specifications.

Laboratory Technician at Lyophilization Technology, Inc.

08/2005 - 02/2007: Formulated, processed and analyzed lyophilized

pharmaceuticals for clinical trial phases I-IV. Participated in and

prepared for FDA audits. Personnel, equipment and water sampling and

monitoring. SAS particulate monitoring. Aseptic processing, CAPPA, method

and process validation, QC testing and technical writing for cGMP lab.

Skills & Certifications

Computer including Word and applications, LIMS, Phoenix, Access, SAS,

Equis, ARCGIS, PointDragon and SAP.

CGMP, GLP and GDP experience.

ISO-9001 Auditor.

Technical writing including validation reports (EQ, OQ, PQ), analytical

reports, COA.

Validation processes (PQ, EQ, OQ)

Six Sigma experience.

Volunteer Activity/Professional Associations:

AAFCO member

AOCS member

ACS member

Led Scholarship Drive for GE Women's Network Scholarship for the

Philadelphia Hub

Philly Volunteer with GE Volunteers

Participated in Science in the Classroom Volunteer Program, Reading Stars

Volunteer Program

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