Andrew Torchia

Past

Sr. Quality Engineer at Genzyme
Supplier Quality Engineer at Bose Corporation
Quality Engineer - In-house Injection Molding at Bose Corporation

Quality Engineer - New Products Group at Bose Corporation

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Education

Northeastern University

Recommended

1 person has recommended Andrew

Connections

168 connections

Industry

Biotechnology

Websites

Andrew Torchia’s Summary

Experienced quality assurance professional providing consulting & contracting services to pharmaceutical, biotechnology and medical device organizations.
Specializing in:
- validation review
- statistical data and trend analysis
- development of quality system metrics
- problem solving, root cause analysis, continuous improvement
- CAPA and deviation investigations
- product complaints handling
- batch record review
- OOS compliance
- change control
- supplier quality management

Andrew Torchia’s Specialties:

ASQ Certified Quality Engineer since 1994
Comprehensive knowledge of cGMP regulations
Experience in all aspects of biotech & pharmaceutical QA compliance
Quality review of validation protocols & final reports
Statistical data analysis and trend analysis
Development of quality system metrics
Problem solving, root cause analysis, continuous improvement
CAPA and deviation investigations
Batch record review
Change control
Supplier quality management

Andrew Torchia’s Experience

Sr. Quality Engineer

Genzyme

(Public Company; 5001-10,000 employees; GENZ; Biotechnology industry)

May 1998 — November 2007 (9 years 7 months)

Managed and administered the Engineering Change Control system. Ensured that all necessary departments participated in the evaluation, implementation, validation, and close-out.

Have Reviewed and approved over 1,000 validation protocols and final reports for all areas and processes of the manufacturing plant. For example clean steam, WFI and other critical utilities, CIP, SIP, lyophilization, fill finish processes, autoclaves, DCS system, computer systems, HVAC systems, cold rooms.

Developed a quarterly plant metrics program. Collected metrics data from a range of departments. Produced and presented a report for plant management.

Led small team that performed all customer complaint investigations and investigations of out of specification test results, environmental monitoring excursions, manufacturing deviations, and metrology discrepancies.

Performed statistical analysis of data as requested by quality management.
Supplier Quality Engineer

Bose Corporation

(Privately Held; 5001-10,000 employees; Consumer Electronics industry)

September 1988 — March 1998 (9 years 7 months)

Managed all quality related issues for a variety of parts - printed circuit boards, CD laser pickup mechanisms, plastic injection molded parts, extrusions, castings, metal stampings, corrugated packaging.

Pursued corrective actions for nonconforming materials.

Performed quality system audits of supplier's manufacturing facilities.

Worked with Bose manufacturing and suppliers to implement suggestions that improved the quality and/or cost of purchased parts.
Quality Engineer - In-house Injection Molding

Bose Corporation

(Privately Held; 5001-10,000 employees; Consumer Electronics industry)

September 1988 — March 1997 (8 years 7 months)

Responsibilities included developing, implementing, and maintaining quality systems for the Bose Westborough injection molding operation.

Assisted in designing the manufacturing processes used in the injection molding operation.

Assisted in training of new injection molding operators.

Acted as main conduit for quality issues concerning injection molded parts produced in Westborough and used by other Bose Facilities.
Quality Engineer - New Products Group

Bose Corporation

(Privately Held; 5001-10,000 employees; Consumer Electronics industry)

September 1988 — March 1997 (8 years 7 months)

Supported manufacturing (electronics and electro-mechanical assembly) with the introduction of all new products introduced at Westborough.

Responsibilities included development of process control plans, analysis of data and report generation, operator training, and participation in quality improvement teams.