Quality Control Customer Service

JUAN B. GARCIA Jr.

**** **** *** *** . *******, Florida 33014

Tel.: 786-***-**** (Cell) . E-Mail:

**************@*****.***

OBJECTIVE

To work with a company where my 22 years of Quality Control & Assurance

experience can contribute to efficient operations and that offers

opportunities for expanding skills, encouraging growth and advancement.

EXPERIENCE

2003- 2009 Noven Pharmaceuticals, Inc. Miami, Florida

QA Supervisor/Shift Lead II (HT and

Controlled Substances)

. Supervise Quality Assurance services for manufacturing processes of

trans-dermal pharmaceutical drugs (HT and Controlled Substances)

maintaining a high level of understanding of relevant production

processes and quality systems.

. Performs the QA review and approval of the following GMP documentation

that has direct impact on the activities performed by, and facilities

utilized in their corresponding areas as applicable: Change Requests,

Batch Records and associated documentation, Product and Component

Release transactions in JD Edwards, provide assistance & support in

Quality Investigations, Validation Plans, Protocols, Reports and

Standard Operating Procedures.

. Execute QA processes including batch record review, product

disposition and quality issue resolution to maintain the flow of

products and documents to meet department & company objectives.

. Ensure strong collaboration between the department and other areas to

ensure consistent application of quality systems & processes.

. Provide training and mentoring of junior members of the QA inspection

group and provide quality oriented guidance to other non-QA employees

within the area supported.

. Monitor and report incidents of non-compliance to QA Management.

. Monitor and report incidents of non-compliance via monthly reports to

upper management. Initiate investigations and non-compliance issues

using Trackwise Systems. Initiate, track and update SOP documents

using Documentum Systems.

. Submit samples to the Analytical /QC labs and Technical Services.

. Review and label components and finished products for disposition

based on QC test results.

. Swab equipment used in manufacturing/packaging and R&D. Perform

inspection and sampling of IQ/OQ/PQ's and product Validation lots.

Perform audits of production areas ensure proper cleaning and

adherence to cGMP and department procedures.

. Started as a Level II Inspector based on knowledge and experience

which grew into the Supervisory level position in November 2008.

. Member of the Noven Volunteer Auditor program which provided

assistance to the senior company auditor in scheduled manufacturing

area audits.

. Performed facility audits of manufacturing and storage areas for

compliance per SOP requirements.

2001-2002 Andrx Corporation, Davie, Florida

QA Senior Inspector for In-Process

Manufacturing

. Performed QA review, release & monitoring for in-process

manufacturing, process validation, and experimental batches of generic

oral dosage pharmaceutical drugs.

. Group Leader (as Senior Inspector)for the QA Group 3rd shift.

Supervised and resolved production, labeling & miscellaneous issues

for QA, manufacturing and packaging groups during shift.

. Reviewed cleaning validations of equipment ensuring proper use on

change over of active ingredients to avoid cross-contamination of

product.

. Reviewed & issued conditional, full release & quarantine labeling

during different phases of production. Evaluated and issued hold &

rejection notices on out of spec or fully rejected product.

. Reconciled manufacturing batch records for accuracy & compliance to

GMP practices prior to final in-process auditing. Conduct sampling &

inspection of non-compliant products prior final review and

disposition (AQL).

. Issued QA audit review reports submitted to management disclosing

discrepancies or GMP violations during shift. Established and

maintained communication with other departments ensuring proper

product flow & scheduling deadlines.

. Promoted to Senior QA Inspector/QA Group Leader (B-shift) within 3

months of hire based on process knowledge and prior job experience.

1999- 2001 CSR Rinker Materials Corp. Miami, Florida

QC Technician/Technical Services Associate,

FEC Quarry

. Sampled and performed in-process and final testing of fine & course

aggregate material in accordance to FDOT, AASHTO & ASTM

specifications.

. Reported daily production test results for adjustments & disposition.

Performed product blend adjustments to conform to customer and FDOT

regulated blending grade specifications.

. Reviewed statistical data (SPC) for product compliance for

specifications and proctors.

. Performed troubleshooting & corrective actions on various mining &

screening systems.

. Reported product test results daily to management & equipment

maintenance to ensure product integrity & quality.

. Achieved certification as a field aggregate testing technician for

FDOT under the QC2000 program.

1995-1998 Dade-Behring Incorporated, Miami, Florida

QC Lab Technician - ISE Quality Control

Department

. Performed in process and final testing of over 31 products for the

CLiNaK & Lytening ISE product line used for patient electrolyte

analysis (caps, electrodes and reagents). Peformed customer complaint

& long-term stability testing.

. Reviewed and performed manufacturing Process Validation testing on

CLiNaK chloride caps & reagents for production in Miami.

. Performed reagent Reference Standard testing of lots for Lytening ISE

& CLiNaK manufactured in Miami & Aguada, Puerto Rico.

. GMP trained on all aspects of ISE/Paramax. Trained in compliance with

ISO-9000/9001 Quality System Standards.

. Maintained product & equipment logs, reagent inventories, and

coordinated with Planning department on production & testing

schedules. Performed maintenance/troubleshooting on equipment used.

. Received excellent job performance reviews for 1996 and 1997 for Dade-

Behring Employee review.

1987-1995 US Gypsum Company, Boston, Massachusetts

QC Technician IV - USG Quality Control

Department

. Performed QC Testing on gypsum and raw materials used in the

manufacturing of wallboard & interior finishes.

. Performed evaluations and stability testing of manufactured products

to meet company, ASTM & Underwriter's Laboratories fireproofing

standards.

. Performed special product enhancement & raw material testing for R&D

and Underwriter's Laboratories.

. Maintained logbooks for laboratory equipment, product retain

inventories, customer complaints, additive calibrations, etc. Reviewed

documentation completed by other analysts.

. Ranked as Chief Wallboard tester because of extensive testing

performed and knowledge of manufacturing processes.

PROFESSIONAL & Technical SKILLS

Computers: Windows XP and Vista based applications, Microsoft Office 2003

and 2007, Dade-Behring Document View 2.01; CSR Rinker' s Microsoft-Access

based ACES (Aggregate Control & Evaluation System), Macola Inventory

Control & Labeling System at Andrx, JD Edwards/DSI Inventory Control, FDGMP

Documentum and Track Wise Quality Management software at Noven.

Quality Control & Assurance: Sample assay testing & statistical analysis

(Medical Diagnostics); pharmaceutical manufacturing & packaging; lot-by-lot

acceptance sampling & testing (AQL);

ISO 9000/9001 controls & documentation; FDA regulated documentation; QA/QC

documentation & controls; soil, sand & aggregate testing; raw & finished

gypsum products & additives testing; manufacturing & testing equipment

calibrations; statistical process control analysis and good laboratory

practices.

EDUCATION & ACCOMPLISHMENTS

1983 Graduated from St. Mary's Regional High School in

Lynn, Massachusetts.

1984-1990 A graduate of the United States Army Chemical School at

Fort McClellan, AL. and a member of the

Massachusetts National Guard as a NBC Specialist.

1984-1986 Have received Massachusetts Army Reserve/National Guard

Army Achievement Medal while serving with the 272

Chemical Company of the 26th Infantry Division.

1989 USG Certificate of Merit for contributions to

Superior Customer Service.

2000 Obtained ACI Aggregate Field Technician

Certification.

2004-Present Senior Member of the American Society for Quality (ASQ),

Certified for Quality Improvement Associate (CQIA), Mechanical

Inspection (CMI) Certification and Quality Technician (CQT)

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