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Daniel Bitler Email & Phone Number

Pharmaceuticals Professional
Location: Lafayette, New Jersey, United States 10 work roles 1 school
1 work email found @nac.net LinkedIn matched
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Role
Pharmaceuticals Professional
Location
Lafayette, New Jersey, United States

Who is Daniel Bitler? Overview

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Daniel Bitler is listed as Pharmaceuticals Professional based in Lafayette, New Jersey, United States. AeroLeads shows a work email signal at nac.net and a matched LinkedIn profile for Daniel Bitler.

Daniel Bitler previously worked as QA Manager at Yoh Scientific and QA Director at Actavis Totowa Llc. Daniel Bitler holds Bs, Forest Science from Penn State University.

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Profile bio

About Daniel Bitler

Daniel Bitler is a Pharmaceuticals Professional.

10 roles

Daniel Bitler work experience

A career timeline built from the work history available for this profile.

Qa Manager

Yoh Scientific
  • SCHERING-PLOUGH, Kenilworth, NJ – 1/09 to 3/09 QA Manager, Pharmaceutical Sciences Quality (contract position)(Contract cancelled due to Merck/SP merger)
  • Receipt, documentation and review of Complaints related to Global Clinical Supplies. All information entered and trended in the TrackWise software program. Direct interaction with CROs/clinical sites to evaluate and.
  • Review and monitoring of Investigations related to Global Clinical Supplies. Provide technical support at Investigational Review Board meetings. Direct interaction with Clinical Supplies Manufacturing, Packaging, and.
  • Gap analysis of 2007/2008 Complaint files. 100% of 2007 files located, compiled and archived. 95% of 2008 files located, compiled and filed; January and February 2008 files archived. Gap analysis of level 2 and level 3.
  • Special projects.
Jan 2009 - Mar 2009

Qa Director

Actavis Totowa Llc
  • Responsibilities revolved around all aspects of the QA function for the manufacturing / packaging locations comprising Actavis Totowa LLC and included the review and resolution of compliance issues related to product.
  • Initiated the formal CAPA program and managed the transfer of the Product Complaint program from RA to QA.
  • Managed the sampling and evaluation of all incoming raw materials, printed materials, and packaging components.
  • Directed the review and approval of all manufacturing/packaging batch records and the associated product releases.
  • Reviewed and final approved change controls, qualification/validation reports, SOPs, product complaints, investigation/deviations, APRs, etc.
  • Represented Actavis as liaison for all third-party customers, including the coordination and management of all third-party customer audits.
Apr 2004 - May 2008

Qa Director

  • Responsibilities revolved around all aspects of the QA function and included the review and resolution of compliance issues related to product quality, QA, cGMP, etc.
  • Evaluated and coordinated the implementation of the TrackWise computer software program for the management of investigations and CAPA.
  • Chaired the Management Review Board, Investigations Review Board, and Change Control Review Board meetings.
  • Managed the sampling and evaluation of incoming raw materials, printed materials and components, the review of manufacturing/packaging batch records and the associated product releases.
  • Reviewed and final approved change controls, qualification/validation reports, SOPs, and investigation/deviations/CAPA documents, and all APRs.
  • Reviewed and assisted in the resolution of compliance issues related to product quality, QA, cGMP, etc.
Apr 2003 - Apr 2004

Qa Director

Sanofi-Synthelabo
  • Responsibilities revolved around all aspects of the QA function for the one North American Sanofi-Synthelabo packaging site; the twenty contract manufacturers in the US, Canada, and Puerto Rico; the 10 co-marketers.
  • Addressed all compliance issues related to QA, cGMP, 21 CFR Part 11, change control, and documentation systems associated with the manufacture of Sanofi-Synthelabo products.
  • Conducted PAI (pre-approval inspection) and mock inspections of several Sanofi-Synthelabo manufacturing sites in Europe for products distributed to the United States.
  • Managed the vendor/supplier auditing program and directly supervised the Manager of Vendor Auditing.
  • Represented the QA department for three due diligence projects related to product acquisition and co-marketing agreements. Served as the QA representative for product launch teams.
Feb 2000 - Apr 2003

Senior Manager, Quality Auditing

  • Responsible for the auditing of over 300 vendors, suppliers, and contract manufacturing/packaging companies for compliance with cGMPs, specifications, SOPs, and filings. These audits were conducted for all divisions of.
  • Collaborated in the development of a program for training and qualifying site auditors at every Warner-Lambert facility worldwide.
Nov 1995 - Feb 2000

Gmp Training And Development Specialist

  • Provided cGMP / compliance / QA training support for the Pharmaceutical Sector manufacturing locations; the research & development group in Ann Arbor, Michigan; and the Pharmaceutical QA group in Morris Plains, New.
  • Collaborated in the development and implementation of a cGMP Orientation Guide for the Warner-Lambert organization.
Oct 1994 - Nov 1995

Manufacturing Gmp Trainer

Warner Lambert (Morris Plains, Nj)
  • As the initial individual in this position, designed and implemented training standards and programs, including developing equipment training manuals, job classification training guides, annual SOP review programs, and.
  • Evaluated and installed a computer interactive program for the training of GMP’s for the aseptic filling area.
Jan 1992 - Oct 1994

Senior Section Head, Sterile Filling Dept.

  • Responsible for the overall operation and cGMP compliance of the afternoon shift Sterile Filling area. Directly supervised a syringe-filling line, a liquid vial-filling line, and an ointment tube-filling line. The.
  • Responsible for training employees on performing Statistical Process Control testing during the filling process and for monitoring product quality, environmental conditions, labor utilization, line efficiencies, and.
  • Directly managed two Supervisors, an Associate Section Head, and over 40 employees.
Jul 1990 - Jan 1992

Manufacturing Supervisor

  • Responsible for supervising filling operations and cGMPs on the Large Volume Parenteral (LVP) glass line, the plastic blow/fill/seal (BFS) lines and the solution preparation area.
  • Was team chairman of a task force that produced annual savings of $300,000 through the more efficient use of personnel and equipment.
Jan 1986 - Jul 1990

Manufacturing Supervisor

  • Supervised the production and packaging of products from 3,000,000 pounds of potatoes and 500,000 pounds of corn weekly.
  • Start-up supervisor during Frito-Lay Corporation’s first Ishida Statistical Weigher and Woodman Universal Bagmaker installation project.
  • Responsible for in-process product and packaged product quality, production scheduling, labor utilization, and resolution of customer complaints.
  • Directly supervised over 50 employees.
Dec 1981 - Jan 1986
1 education record

Daniel Bitler education

FAQ

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What is Daniel Bitler's role at their current company?

Daniel Bitler is listed as Pharmaceuticals Professional.

What is Daniel Bitler's email address?

AeroLeads has found 1 work email signal at @nac.net for Daniel Bitler.

Where is Daniel Bitler based?

Daniel Bitler is based in Lafayette, New Jersey, United States.

What companies has Daniel Bitler worked for?

Daniel Bitler has worked for Yoh Scientific, Actavis Totowa Llc, Alpharma, Sanofi-Synthelabo, and Warner Lambert.

How can I contact Daniel Bitler?

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What schools did Daniel Bitler attend?

Daniel Bitler holds Bs, Forest Science from Penn State University.

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