John M. Caruso

** ***** ****

Neshanic Station, NJ 08873

908-***-****

ac515a@r.postjobfree.com

EXPERIENCE: JOHNSON & JOHNSON INC. New Brunswick, NJ

Sr. Analyst-Records Management

Sept. 2008 – Feb 2018

Manage off-site storage of all hard copy records for J & J Corporate (approx. 85,000 boxes)

Initiate the use of Iron Mountain data base for the storage and retrieval of off-site records (System Administrator)

Trained over 100 records coordinators on the use of the new database.

System Administrator for Documentum system for the review and approval of all corporate IT Validation Protocols, reports, and decommissions of systems.

Trained all corporate IT associates on the use of the Documentum system.

Backup for the Corporate Records Manager

Responsible for $300,000 budget for off-site storage, reconciled 6 accounts and created all purchase orders in Ariba for Records Management.

ORTHO BIOTECH INC. Raritan NJ

Process Quality Specialist

March 2003 - Sept. 2008

Release Ortho Biotech/PSGA Intermediate and Finished Products.

Conduct internal audits of manufacturing facilities and all documents associated with the manufacture of products produced in the Raritan Biological Manufacturing Facility(RBMF).

Perform incoming inspections of raw materials, components, and processing aides associated with the production for Biotech/PSGA products.

Review and approve maintenance requests for the RBMF.

Establish department Standard Operating Procedures covering the responsibilities and functions of the Process Quality Specialist/QA and revising documents as needed.

Sr. Document Control Specialist and Customer Complaints Administrator

Sept. 1995 to March 2003

Administer various Ortho Biotech documents series and manage the review, approval and distribution process.

Train other Document Control associates in administrating documents control series and perform department procedures; document and assess the training of these procedures.

Provide technical assistance to authors and reviewers throughout the document initiation, review, and approval process.

Establish department Standard Operating Procedures covering the responsibilities and functions of the Document Control Department, revising documents as needed.

Supervise temporary employees.

Release raw materials and Ortho Biotech Finished Products.

Train other employees in the Product Quality Management System (PQMS Compliant System).

Administrator of all Ortho Biotech Product Complaints.

Perform product complaint investigations on all Ortho Biotech Products.

Review and approve all Ortho Biotech Product Complaints.

Provide input for the implementation of OneSource (Documentum).

Site Coordinator for the migration of all documents into OneSource System for Raritan Bio (Biotech).

Senior Regulatory Documentation Specialist

Aug. 1993 to Sept. 1995

Provide input to regulatory documents including INDs, PLA/ELA’s, CPMP Dossiers,

Annual Reports and Amendments to existing regulatory documents.

Coordinate review process of all regulatory documents associated with Quality and related functions.

Write reports for sections of regulatory filings for which Quality is responsible, using data or documents collected form appropriate departments,

Prepare procedures, specifications and guidelines as necessary.

Senior Research Associate

Oct. 1989 to Aug. 1993

Perform release testing of Ortho Biotech products using HPLC, IE, and GPC, SDS/Polyacrylamide, IEF and IEP gel electrophoresis.

Perform raw material testing including water testing and associated physical testing.

Manage calibration and maintenance of all lab test equipment.

Prepare laboratory reports.

Review release data.

CYTOGEN CORPORATION, Princeton, NJ

Research Associate

Sept. 1986 to Oct. 1989

Prepare and purify monoclonal antibodies and perform the associated testing.

Scale-up and preparation of clinical antibodies for clinical trials.

Perform basic research.

EDUCATION: BA Biology, Rutgers College, Rutgers University

PROFESSIONAL AFFILIATES/AWARDS

Member American Society for Quality

J&J Achievement Award

Standards of Leadership Awards. (2)

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