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Robert Wittrock Email & Phone Number

Senior QA Auditor at ACI Clinical
Location: Greater Philadelphia, United States, United States 4 work roles 3 schools
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Current company
ACI Clinical
Role
Senior QA Auditor
Location
Greater Philadelphia, United States, United States
Company size
75 employees

Who is Robert Wittrock? Overview

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Quick answer

Robert Wittrock is listed as Senior QA Auditor at ACI Clinical, a company with 75 employees, based in Greater Philadelphia, United States, United States. AeroLeads shows a matched LinkedIn profile for Robert Wittrock.

Robert Wittrock previously worked as Senior Auditor / QA Auditor II at Pharmaceutical Product Development and Senior Scientist at Merck & Co.. Robert Wittrock holds Master'S Degree, Molecular Biology from Villanova University.

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ACI Clinical

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Profile bio

About Robert Wittrock

Over 20 years of basic and clinical research experience in the pharmaceutical and CRO industries in various positions. Most recently, I’ve furthered my professional development in a clinical lab compliance capacity as an auditor in clinical Global Quality and Compliance. My current position applies GxP principles to Endpoint Adjudication and Data Monitoring Committee functions. My current position (2019) is in supporting ACIs parent company, WCG (WIRB-Copernicus) as an auditor in the Quality Assurance Information Technology CSO organization. Key accomplishments: • Co-developed a site-centralized event & CAPA system enhancing the sharing of best-practices throughout the site via a centralized non-conformance event tracking system. This allowed me to work with the laboratories to develop effective and meaningful corrective and preventative actions.• Member a Clinical lab effort which provided critical clinical data support for the HPV Quadrivalent Vaccine Program. Primary responsibilities included purification, screening and data analysis of ~18,000 phase II/III clinical trial samples per week, leading to FDA approval of Gardasil, the world’s first HPV virus vaccine. Specialties: • Internal audits - Conducted internal system and process audits, written audit finding reports, collected and evaluated responses and provided periodic metrics. • External (vendor) audits - Conducted vendor audits, including production of audit plans, reports, collection of responses and follow up.• Hosting of external audits: for clients and regulatory agencies including internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.• Computer system validation and review: Experience with computer system validation including designing test scripts, execution of validation testing and QA review of all pertinent documentation.

Current workplace

Robert Wittrock's current company

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ACI Clinical
Aci Clinical
Senior QA Auditor
pennsylvania, united states
Website
aciclinical.com
Employees
75
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4 roles

Robert Wittrock work experience

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Senior Qa Auditor

Current
Aci Clinical

Remote

  • Schedule, prepare and perform internal system and process audits and report the status of the quality levels of staff, systems and production activities to the Manager of Quality Assurance and management team (as.
  • Schedule, prepare and conduct vendor qualification audits. Including production of audit plans, reports, collection of responses, and follow up
  • Assist in hosting external audits and inspections including communication with sponsor/agency, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings.
  • Perform Quality Control (QC) reviews for SOP, study specific and general training documentation, Corrective Actions Preventative Actions (CAPA) and Change Control logs
  • Review, approve and analyze both internal and external compliance related issues and reports, corrective and preventive actions (CAPA), deviations and notes to file (NTF)
  • Keep current with all related quality legislation and compliance issues and provide guidance to ACI employees on regulatory and quality issues
Jan 2016 - Present

Senior Auditor / Qa Auditor Ii

Pharmaceutical Product Development

Wayne, PA

Lead and conduct internal lab facility and procedural audits.Conduct external vendor audits.Documentation Management: Support SOP writing and revisions.CAPA process support: System maintenance and metricsApplication of GMP guidelines in Vaccine and Biologics laboratory operations (GxP)Share best practices site-wideParticipate and hosts client audits

Nov 2011 - Dec 2015

Senior Scientist

Merck & Co.

West Point, PA

Clinical Research Lab supporting the initial filing for GARDASILMember of the HPV Clinical PCR group which provided critical clinical data support for the HPV Quadrivalent Vaccine Program. Primary responsibilities included purification, screening and data analysis of ~18,000 phase II/III clinical trial samples per week. Responsibilities also included.

May 2003 - Jan 2009

Senior Scientist

Glaxosmithkline

Research team member charged with development and evaluation of a Hepatitis C virus inhibitor compound. This effort contributed to the rapid developmental progression of this representative class of compounds from proof of concept to an IND filing in 2002. Achieving this goal resulted in award-winning recognition throughout GSK R&D. Key responsibilities.

Mar 1996 - Apr 2003
Team & coworkers

Colleagues at ACI Clinical

Other employees you can reach at aciclinical.com. View company contacts for 75 employees →

GB Glen Bromley Glen Bromley Colleague at Aci ClinicalPhiladelphia, Pennsylvania, United States, United States View → MK Mamo Killo Mamo Killo Colleague at Aci ClinicalMonroe, Georgia, United States, United States View → BS Bill Stedman Bill Stedman Colleague at Aci ClinicalNorristown, Pennsylvania, United States, United States View → GL Gabriel Lord Gabriel Lord Colleague at Aci ClinicalSun Prairie, Wisconsin, United States, United States View → CL Christine Letizia Christine Letizia Colleague at Aci ClinicalGreater Chicago Area, United States View → VM Vijay Moolaveesala Vijay Moolaveesala Colleague at Aci ClinicalGreater Philadelphia, United States View → DB David Beecher David Beecher Colleague at Aci ClinicalBala-Cynwyd, Pennsylvania, United States, United States View → KK Kiran K. Kiran K. Colleague at Aci ClinicalMilwaukee, Wisconsin, United States, United States View → CZ Christoph Zablocki Christoph Zablocki Colleague at Aci ClinicalWrocław, Dolnośląskie, Poland, Poland View → GE Gretchen Ellis Gretchen Ellis Colleague at Aci ClinicalAmbler, Pennsylvania, United States, United States View →
3 education records

Robert Wittrock education

FAQ

Frequently asked questions about Robert Wittrock

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What company does Robert Wittrock work for?

Robert Wittrock works for ACI Clinical.

What is Robert Wittrock's role at ACI Clinical?

Robert Wittrock is listed as Senior QA Auditor at ACI Clinical.

Where is Robert Wittrock based?

Robert Wittrock is based in Greater Philadelphia, United States, United States while working with ACI Clinical.

What companies has Robert Wittrock worked for?

Robert Wittrock has worked for Aci Clinical, Pharmaceutical Product Development, Merck & Co., and Glaxosmithkline.

Who are Robert Wittrock's colleagues at ACI Clinical?

Robert Wittrock's colleagues at ACI Clinical include Glen Bromley, Mamo Killo, Bill Stedman, Gabriel Lord, and Christine Letizia.

How can I contact Robert Wittrock?

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What schools did Robert Wittrock attend?

Robert Wittrock holds Master'S Degree, Molecular Biology from Villanova University.

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