Brian C. Amell

*** ******* *** ***** ****, Buffalo, NY, 14222

732-***-****

Email: accs3i@r.postjobfree.com

Quality Engineer offering nine years of experience working in a cGMP, cGLP

and ISO 13485 compliant environment with, internal audit, laboratory

testing, CAPA, and production experience.

Expertise

. Quality auditing according to 21 CFR part 820

and ISO 13485.

. CAPA and CAPA-related activities.

. Product/material testing using appropriate analytical methods,

including HPLC, TLC, FTIR, UV-Vis, and Karl Fischer.

. Creation and revision of Standard Operating Procedures

and other documents.

. Change order initiation and approval.

EDUCATION AND TRAINING

University at Buffalo, The State University of New York,

Bachelor of Science, Medicinal Chemistry (May, 2008).

Auditing in a cGMP Environment, Continuing Education Course (November,

2009).

ISO 13485 Internal Auditor Training (June 2012).

OSEA, Inc.

HAZWOPER, 8 hour Course, OSEA, Inc. (July, 2011).

The Dorsey Group LLC

High Performance Work Team, Ten Week Course (December, 2011).

RELEVANT EXPERIENCE

CAPA Quality Engineer May 2013 - Current

Baxter International, Inc. Medina, New York (Aerotek)

. Execute all CAPA-related activities within the company, including

identification of quality problems associated with products, processes,

and the Quality System.

. Conduct CAPA investigation, containment, corrective/preventive action,

and verification of effectiveness.

. Mentor CAPA Owners and CAPA investigators in developing investigation

plan and documenting each step of process.

. Collaborate with CAPA Owners and Investigators to ensure timely

completion of CAPA activities

. Report on CAPA progress and metrics.

. Perform CAPA corrective or corrective action activities such as

collaborating with subject matter experts and process owners on the

creation of and revision of internal documents..

. Serve as subject matter expert for the CAPA process.

. Prepare CAPA to be presented to CAPA Review Board for review and approval

at each stage of process.

. Manage CAPA to ensure timeliness of completion.

. Provide training, as needed.

. Identify, implement, and monitor CAPA process improvements to ensure

continuous improvement to process quality.

Laboratory Technician I August 2008 - March 2009

Senior QA/QC Technician March 2009 - May 2013

Life Technologies, Inc. Grand Island, New York

. Developed training curricula and trained new hires according to company

procedures and cGMP/cGLP.

. Lead internal audit teams according to ISO 13485 standard and 21 CFR part

820 and documented any non-conformances, approved Corrective

Action/Preventative Action (CAPA), and coordinated effectiveness checks

using Trackwise.

. Responded to assigned CAPAs related to audit observations and provided

investigation, root cause analysis, and correction/corrective action,

ensuring closure within the assigned timeline.

. Served as Subject Matter Expert and Technical Representative at Material

Review Board and Supplier Review Board. Presented raw material and

supplier issues to Quality, Procurement, and Manufacturing Sciences staff

and collaborated on resolution.

. Reviewed, updated, and collaborated on the creation of Standard Operating

Procedures, Work Instructions, and Forms.

. Approved Change Orders involving the creation and revision of new raw

material specifications, ensuring supplier documentation met compendial

and internal standards and specifications.

. Collaborated with Procurement department to evaluate new chemical

suppliers, ensuring materials met internal specifications for supplier

approval.

. Compiled departmental metrics and presented at weekly Natural Work Group

meeting.

. Performed required testing on raw materials, in-process material, and

finished goods using appropriate analytical methods, including HPLC, TLC,

FTIR, UV-Vis, and Karl Fischer.

. Entered and approved data associated with raw materials and finished

products using LIMS and ERP systems.

Laboratory Technician - Research and Development/Athena Production

December 2003 - December 2006

Zeus Scientific, Inc., Raritan, New Jersey.

. Calibrated immunoassay kits, tabulated, and interpreted associated

data.

. Executed validations and compiled reports.

. Manufactured buffers and controls for use in immunoassay kits.

. Maintained and ordered inventory necessary for production.

. Reviewed standard operating procedures associated with personal

responsibilities.

. Calibrated and maintained machinery and computers necessary to run

immunoassays.

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