QA Professional with 17+ Years of GxP QA Experience, Seeking New Role

JOHN TRUNCALE

* ******** **** *****, ***. #****

Rahway, NJ 07065-5183

Phone: 732-***-****

Email: *************@*****.***

SUMMARY:

I have more than seventeen (17+) years of pharmaceutical industry experience, which includes extensive exposure to various aspects of GxP Compliance functions. After having taken an extended leave of absence to care for a terminally ill family member, I have returned to the workforce rejuvenated and re-energized, and I am now seeking a position that will further strengthen and challenge my industry knowledge base and continue my personal development along this career path.

EXPERIENCE:

Prolong Pharmaceuticals, LLC South Plainfield, NJ

Senior QA Auditor June 2017 – present

Provide QA support/approval for all cross-funtional departments.

Review/approve QMS records (i.e., Deviations, CAPAs, and Change Controls) (since company re-organization).

Review/approve executed batch records and perform finished product lot disposition for potential Clinical Trial Materials (since company re-organization).

Review/approve Method Qualification/Validation protocols and reports, as well as Product Development Reports for R&D (since company re-organization).

Supported development and implementation of robust internal audit and external audit/vendor management programs.

Conduct vendor audits for CMOs, raw material manufacturers, and single-use component manufacturers affiliated with Prolong.

Conduct routine internal audits for all GxP-related departments (GMP and GCP).

Collaborated with Clinical Operations and Clinical Development departments to develop and implement an in-house Clinical QA program.

Conducted 100% data verification for eleven (11) Clinical Study Reports (CSRs) and one (1) Regulatory Briefing Document.

Extended leave from workforce due to terminally ill family member April 2015 – May 2017

G&W Laboratories, Inc. South Plainfield, NJ

Senior Manager, Quality Operations May 2013 – March 2015

Managed five (5) In-Process QO Inspectors, and one (1) QO Supervisor, whose responsibilities included the performance of in-process QO checks during batch manufacturing and packaging, room/line clearances, Quality Hold System administration, and administration of the QO Retain Sample program for in-process and finished products.

Managed two (2) Incoming QO Inspectors, whose responsibilities included the inspection and sampling of incoming raw materials and packaging components, re-sampling of raw materials/components for re-test/investigation purposes, and purified water sampling.

Reviewed/approved protocols and reports associated with Cleaning Validation, and Process Validation, as well as Clinical Batch Manufacturing and Packaging.

Supported in-house cGMP customer audits and Regulatory inspections (FDA, etc.) as needed.

Authored/approved department-specific documents, including: investigations, SOPs, Forms, and training syllabi.

Halo Pharmaceutical, Inc. Whippany, NJ

Manager, Quality Assurance May 2010 – April 2013

Managed five (5) QA Inspectors, and one (1) Team Leader, whose responsibilities included the inspection, sampling and disposition of incoming raw materials and components, manufacturing and packaging in-process QA checks, room/line clearances, and purified water sampling.

Managed two (2) QA Batch Disposition Specialists, whose responsibilities included: production record issuance and review, QA Hold System administration, and finished product disposition.

Interacted with Customer QA contacts to facilitate lot release and/or resolve product-related issues.

Reviewed/approved protocols and reports associated with Clinical/Submission Batch Manufacturing and Packaging, Analytical Methods Validation, Cleaning Validation, and Process Validation.

Routinely conducted internal and external audits, typically serving as lead auditor.

Hosted/supported in-house cGMP customer audits and Regulatory inspections (FDA, DEA, etc).

Authored/approved department-specific documents, including: investigations, SOPs, Forms, and training syllabi.

Actavis Elizabeth LLC Elizabeth, NJ

Supervisor, QA Documentation (Change Administration) July 2009 – May 2010

Supervised three (3) QA Documentation Specialists in the Change Administration group (including training, mentorship, performance reviews and resolution of personnel issues).

Administered the site-specific Change Control program and facilitated bi-weekly CCRB meetings.

Authored/revised department-specific SOPs and other controlled documents as needed.

Authored and reviewed Deviation investigations associated with the QA Documentation group.

Created and maintained training syllabi for QA Documentation personnel.

Performed biennial audits of Change Control documents and process-related SOPs/Forms.

Provided cross-functional support for the QA Production Support Supervisor in her absence.

King Pharmaceuticals, Inc. (formerly Alpharma Pharmaceuticals LLC) Piscataway, NJ

Senior QA Associate (Development QA) May 2007 – June 2009

Conducted GCP audits of clinical investigator sites and Clinical Research Organizations (CROs).

Conducted cGMP audits of raw material/component vendors and contract laboratory facilities.

Authored/approved SOPs/Forms to establish QA systems for the Analytical Chemistry, Product Development, and Clinical Development groups.

Audited CMC data for IND/NDA Submissions.

Performed QA Closure Approval for Deviations & CAPAs related to R&D products.

Authorized final QA disposition of R&D product lots for clinical and IND/NDA Submission use.

Performed final QA Approval for PD Protocols/Reports, Analytical Methods and Method Validation documents, Product Specifications and Master Production Record documents for R&D products.

Served as primary QA contact for affiliated Contract Manufacturing Organizations (CMOs).

Actavis Elizabeth LLC (formerly Alpharma USHP) Elizabeth, NJ

Senior R&D QA Specialist April 2005 – May 2007

Authored, revised and approved SOPs/Forms to establish QA Systems for the AD/PD groups.

Performed QA Closure Approval for Deviations & CAPAs related to R&D products.

Authorized final QA disposition of R&D product lots for clinical and ANDA Submission use.

Performed final QA Approval for PD Protocols/Reports, Analytical Methods and Method Validation documents, Product Specifications and Master Production Record documents for R&D products.

Provided support to Site QA Management during PAIs and annual FDA Site Inspections.

Investigation Specialist/Senior Investigations Specialist August 2003 – April 2005

Authored and reviewed Deviation investigations, in compliance with cGMPs and SOP requirements.

Performed routine Deviation trending to evaluate CAPA effectivity.

ImClone Systems Incorporated Branchburg, NJ

QA Product Disposition Specialist June 2002 – August 2003

Reviewed batch records and provided QA disposition for product intermediates and solution lots.

QA Inspector April 2001 – June 2002

Performed incoming inspection, sampling and disposition activities for raw materials/components.

TRAINING/CERTIFICATIONS:

03/2019 – 05/2019 – 30-Hour Clinical Research Auditing Certification Program [Barnett International]

09/2011 – Packaging & Labeling: Quality Management Systems [GSMI]

10/2008 – Auditing Clinical Trials for GCP Compliance [PTI International]

09/2008 – Analytical Methods Validation for FDA Compliance [CfPA]

11/2007 – GMP Compliance Auditing [Pharmanet, Inc.]

06/2006 – Investigating Out-of-Specification Results [IVT/Advanstar]

12/2005 – Lean Six Sigma Green Belt Training [Alpharma Six Sigma Academy]

08/2004 – Solid Dosage Manufacturing 101 [DI Pharma Tech]

07/2002 – Batch Record Review & Investigations [Pharmanet, Inc.]

SPECIAL PROJECTS:

12/2005 to 04/2006: Lean Six Sigma (LSS) Green Belt Project Team Leader

Project Goal: Reduce average R&D deviation cycle time from 30 days to 10 days.

10/2004 to 04/2005: Lean Six Sigma (LSS) Green Belt Project Team Member

Project Goal: Reduce number of overdue CAPAs from 52% to <10% per month.

04/2004 to 04/2005: Lean Six Sigma (LSS) Black Belt Project Team Member

Project Goal: Reduce average deviation cycle time by 50% (from >53 days to ~26 days).

EDUCATION:

01/1999 to 05/2003: Rutgers University, Cook College New Brunswick, NJ

Degree Program: B.S., Biotechnology

Completed 95.5 credit hours (128-hour program requirement)

Leave of absence since 05/2003

09/1997 to 12/1998: Boston University, College of Arts & Sciences Boston, MA

Degree Program: B.A., Microbiology & Biochemistry

Completed 46.0 credit hours with a 3.0 GPA (out of 4.0 scale) at the time of transfer

SKILLS/PROFICIENCIES/MEMBERSHIPS:

Working knowledge of VEEVA QualityDocs and QMS, TRACKWISE, QUMAS, SAP (R/3 and Business One), ADOBE ACROBAT Pro, MS OFFICE (Word, Excel, PowerPoint & Access), MINITAB and JD EDWARDS.

ASQ member since 2003.

REFERENCES:

Furnished upon request.

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