Customer Service Quality Assurance

Juan B. Garcia

**** **** *** *** *******, Florida 33014 • 786-***-**** • *********@*****.***

Quality Control and Assurance Specialist

Pharmaceutical Manufacturing & Packaging /Mining and Manufacturing Quality Control and Technical Support

Over 22 years experience ensuring superior customer service and support with diverse experience in pharmaceutical in-process manufacturing (solid dosage & trans-dermal), technical and quality support for aggregate mining and building material manufacturing (wallboard and interior finishes), and medical devices (serum, whole blood and urine analyzers). I am a highly motivated, professional and ethical in accordance to the American Society for Quality Code of Ethics. I posses exceptional communication and problem solving skills to ensure superior process/product quality and customer satisfaction. I am experienced in corrective and preventative action (CAPA), complaint investigation/testing with Supervisory experience.

Established achievements in:

Internal/External customer service and technical support.

Ensuring quality assurance, safety and cGMP compliance of manufacturing processes.

Compliance and proficiency on FDA, DEA, FAA, AASHTO and ASTM regulations and procedures.

Providing support/guidance/training/mentoring for the QA Inspector staff.

Assisting in inter-departmental queries for product/process investigations.

Investigational and trouble-shooting skills on out of compliance issues.

Monitoring and trending incidents of non-compliance, batch record error rates and product holds/rejections for management reports.

Member of the Noven Volunteer Auditor program providing assistance to the Senior Auditor in scheduled internal audits.

Performed Facility Audits of the manufacturing and storage areas for compliance.

Initially hired as a QA Inspector II which advanced to the Senior Inspector and Supervisor/Shift Lead II positions within 5 years based on knowledge and experience.

CORE PROFICIENCY IN

• Quality Control/Assurance • Documentum ECM • SOP Review/Revision

• Microsoft Office • JD Edwards One World XE • Specifications & Testing

• Trackwise EQMS • Validation Support • Superior Customer Service

CAREER ACHIEVEMENTS

• Armed Services – USARNG Service as an NBC Specialist with the Massachusetts National Guard (1984-1990). Recipient of the US Army Achievement Medal for meritorious service (1984-1986). Honorably discharged in 1990.

• ASQ Senior Member – American Society for Quality with three lifetime certifications obtained for Quality Improvement Associate (CQIA), Quality Inspector (CQI) and Quality Technician (CQT).

• ACI Certification – American Concrete Institute Certified Aggregate Field Technician (2000 – 2005).

• Employer Service Awards – Received Certificate of Merit for Superior Customer Service at United Stated Gypsum (1989). Recipient of the Manufacturing Excellence and Certificate of Special Recognition at Noven Pharmaceuticals (2005-2006).

PROFESSIONAL EXPERIENCE

Aerotek Staffing, Miami Lakes, Florida Nov 2010 – Present

QC Incoming/Outgoing Specialist

• Perform quality inspection of cosmetics (incoming and outgoing orders) for client (Urban Decay, LLC in Hialeah, Florida).

• Ensure accuracy of orders prior to storage or shipment; verifying correctness in item/batch, quantity, appearance, etc. per CFR Title 21 regulations for cosmetics.

• Initiate and report corrective action requests to corporate offices in California for disposition order.

• Perform inspection of RTV (return to vendor) from retail clients and customer/retail client complaints. Report inspections and disposition material for return to stock or proper disposal.

Adecco Engineering & Technical Staffing , Miami, Florida May 2010 – Oct 2010

QA Outbound Inspector

• Performed quality inspection of outbound part orders for client (BE Aerospace Inc. in Doral, Florida.

• Ensured accuracy of orders prior to shipment; verifying correctness in parts, quantity, specifications and certifications.

• Initiated corrective action requests for orders or parts not certified by originator, or which did not meet standards prior to shipment.

• Performed incoming quality assurance verifications of parts when needed, performing random sampling & measurements per ANSI/ASQC Z1.4 and originator drawings and specifications and FAA regulations.

Noven Pharmaceutical Inc, Miami, Florida Aug 2003 – Dec 2009

QA Supervisor/Shift Lead II

• Provided supervisory oversight for QA Inspectors and Operations in trans-dermal manufacturing and packaging of Hormone Therapy and Controlled Substances products. Reviewed or performed release of operation processes and components when needed.

• Performed batch record reviews for errors and compliance, product dispositions for non-conformance components or finished products and review and revision of department procedures and forms.

• Monitored and mentored QA staff to ensure compliance to cGMP practices. Maintained training records for 2nd shift QA personnel and SOP binders in the operation areas.

• Monitored and reported incidents of non-compliance and unplanned deviations to QA Management. Initiated investigations in Trackwise Quality Management software and hold dispositions in JD Edwards One World XE Inventory System when necessary.

• Scheduled/provided support for product, process, equipment and cleaning validations (IQ/OQ/PQ). Reviewed and provided department affirmation for planned deviations of procedures when necessary. Provided/scheduled support for equipment swabs and micro sampling.

• Primary QA interface on the 2nd shift for internal customers to address, assist and resolve quality issues. Provided quality oriented guidance to operations personnel and provided assistance when necessary on open investigations and vendor non-compliance issues. Conducted positive/cooperative/transparent/informative communications with all company departments.

• Performed investigations with supplemental actions such as CAPA (corrective and preventive action), root cause analysis, updating procedures via change controls and effectivity analysis of corrective actions to ensure issue will not re-occur.

• Ensured proper sample processing and QC lab submittals for testing. Provided assistance when required for destructive sampling and inspection of packaging operations. Reviewed and labeled components and finished product for disposition. Provided support for R&D when required.

Andrx Corporation Davie, Florida Aug 2001 – Nov 2002

QA Senior Inspector for In-process Manufacturing

• Group Leader for QA Inspectors for support of component dispensing, spray fluid bed coating, pan coating, blending, tablet and encapsulation processes for commercial and experimental batches of generic oral dosage pharmaceutical drugs.

• Supervised review/release/monitoring of production areas for 5-6 inspectors for the 12 hour shift. Provided assistance & guidance to inspectors for cleaning validations of equipment ensuring proper cleaning and use on change-over of active ingredients to avoid cross-contamination of product.

• Resolved production, labeling and miscellaneous issues for QA and manufacturing areas during the shift. Reconciled manufacturing batch records for accuracy and cGMP compliance. Scheduled/conducted AQL sampling and inspection of non-compliance product when required.

• Reviewed and issued disposition labeling of product for the different production stages. Evaluated and issued Hold or Rejection notices for material when required. Established and maintained

constructive communications with other departments to ensure efficient process flow and scheduling.

• Issued QA audit review reports submitted to management disclosing any non-compliance issues which may have occurred during a shift.

• Promoted to Senior QA Inspector/Group Leader within 3 months of hire based on process knowledge and experience.

CSR Rinker Materials Corp Miami, Florida May 1999 – Jul 2001

QC Technician/Technical Services Associate

Performed in-process and final product sampling and testing of fine and coarse aggregate material mined at the FEC quarry in accordance to AASHTO, FDOT and ASTM specifications.

Evaluated and adjusted process based on test results using statistical process control (SPC) methods for compliance to specifications, blending grade specifications and customer proctors. Performed systems troubleshooting and corrective actions on various screening systems when needed to ensure compliance.

Reported product test results daily to management and equipment maintenance to ensure product integrity and quality.

Assisted FDOT On-site inspectors when necessary during monthly on-site inspections.

Dade-Behring, Inc Miami, Florida Dec 1995 – Aug 1998

QC Lab Technician

Performed in-process and final testing of over 31 products for the Lytening and CLiNak Ion Selective Electrode (ISE) product line used for patient electrolyte evaluation. Performed statistical analysis of results based on assay sampling of reagents, caps and electrodes.

Performed customer complaint testing and long term stability testing of components. Maintained product and equipment logs, component inventories and coordinated with Planning on production and testing schedules.

Trained in compliance with ISO-9000-9001 Standards. GMP trained on all aspects (manufacturing processes and testing procedures) of Lytening/CLiNaK product line.

Performed maintenance/troubleshooting of equipment used. Performed Reference Standard and Process Validation of reagents and components when necessary.

Received excellent job performance reviews in 1996 and 1997.

USG Company Boston, Massachusetts Apr 1987 – Aug 1995

QC Technician IV

Performed QC testing of gypsum, raw materials and finished product (wallboard and interior finishes). Performed special product and raw materials testing for R&D and Underwriters Laboratories when required.

Performed product evaluations and stability testing of raw materials and finished product to ensure compliance to company, ASTM and UL fireproofing standards.

Maintained laboratory equipment logbooks, retention inventories, customer complaint samples, additive feeder calibrations. Reviewed inspection documentation for compliance and accuracy.

Ranked as Chief Wallboard tester due to knowledge of manufacturing process and finished products. Sampled and tested raw gypsum during deliveries by ship from Nova Scotia, Canada.

EDUCATION

High School Diploma, St. Mary’s Regional High School Lynn, Massachusetts 1983

Enrolled in Colorado Technical University to pursue a degree in Business Planning

Tentative graduation date for Associates Degree: September 2011

Tentative graduation date for Bachelor’s Degree: September 2013

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