Sheila Burns

Sheila Burns Email and Phone Number

QA Supplier Qualification and Auditing Lead @ Spark Therapeutics, Inc.
Philadelphia, PA, US
Sheila Burns's Location
Greater Philadelphia, United States, United States
Sheila Burns's Contact Details

Sheila Burns personal email

n/a
About Sheila Burns

Sheila Burns is a QA Supplier Qualification and Auditing Lead at Spark Therapeutics, Inc.. She possess expertise in change control, gmp, gxp, capa, fda and 24 more skills.

Sheila Burns's Current Company Details
Spark Therapeutics, Inc.

Spark Therapeutics, Inc.

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QA Supplier Qualification and Auditing Lead
Philadelphia, PA, US
Sheila Burns Work Experience Details
  • Spark Therapeutics, Inc.
    Qa Supplier Qualification And Auditing Lead
    Spark Therapeutics, Inc.
    Philadelphia, Pa, Us
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  • Spark Therapeutics, Inc.
    Associate Director, Qa Supplier Qualification & Auditing
    Spark Therapeutics, Inc. Jul 2023 - Present
    Philadelphia, Pa, Us
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  • Spark Therapeutics, Inc.
    Qa Supplier Qualification & Auditing Lead
    Spark Therapeutics, Inc. Feb 2021 - Jul 2023
    Philadelphia, Pa, Us
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  • Spark Therapeutics, Inc.
    Sr. Qa Specialist - Compliance
    Spark Therapeutics, Inc. Apr 2017 - Feb 2021
    Philadelphia, Pa, Us
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  • Endo Pharmaceuticals
    Principal Auditor, Enterprise Quality Auditing
    Endo Pharmaceuticals Mar 2015 - Apr 2017
    Malvern, Pa, Us
    Perform domestic and international external audits of contract manufacturers (oral solid dosage, sterile injectable, combo product), packaging facilities (primary and secondary), laboratories, API and raw material manufacturers, warehousing and distribution services, GMP service providers, etc.Perform internal audits of the various Endo business units worldwide (business units consist of virtual contract manufacturing oversight and internal manufacturing facilities for oral solid dosage, liquids, biologics, and sterile injectable). Manage the annual internal and external audit schedules.Develop and assist in the development of processes and procedures for the Enterprise Quality Auditing function.
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  • Endo Pharmaceuticals
    Principal Qa Specialist
    Endo Pharmaceuticals Jul 2011 - Mar 2015
    Malvern, Pa, Us
    Responsible for providing quality oversight to vendors that provide contract services (API, bulk and finished product manufacturing, primary and secondary packaging, and contract laboratory testing) for established products, those undergoing technology transfer and new product launches.
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  • Morphotek, Inc.
    Senior Qa Specialist
    Morphotek, Inc. Nov 2009 - Jul 2011
    Supported quality processes for work performed by Morphotek, and by Morphotek contractors, relative to various therapeutic antibodies (molecules) in clinical development.
  • Centocor
    Sr. Compliance Associate
    Centocor Dec 2004 - Nov 2009
    Us
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  • Centocor
    Qa Associate Ii
    Centocor Nov 2002 - Dec 2004
    Us
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  • Dupont Pharmaceuticals
    Packaging Engineer
    Dupont Pharmaceuticals Oct 2001 - Sep 2002
    Us
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  • Dupont Pharmaceuticals
    Technical Packaging Specialist
    Dupont Pharmaceuticals 1999 - Oct 2001
    Us
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  • Dupont Pharmaceuticals
    Packaging Documentation Coordinator
    Dupont Pharmaceuticals 1997 - 1999
    Us
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Sheila Burns Skills

Change Control Gmp Gxp Capa Fda Pharmaceutical Industry Aseptic Processing Biopharmaceuticals Technology Transfer Quality Auditing Biotechnology Trackwise Sop External Audit Batch Release Corrective And Preventive Action Quality Assurance U.s. Food And Drug Administration 21 Cfr Part 11 Standard Operating Procedure Validation Cmo Management Asq Member Product Launch Deviations Process Validation Generic Drugs Change Management Document Review

Sheila Burns Education Details

  • Immaculata University
    Immaculata University
    Business
  • Delaware Technical & Community College
    Delaware Technical & Community College
    Chemistry

Frequently Asked Questions about Sheila Burns

What company does Sheila Burns work for?

Sheila Burns works for Spark Therapeutics, Inc.

What is Sheila Burns's role at the current company?

Sheila Burns's current role is QA Supplier Qualification and Auditing Lead.

What is Sheila Burns's email address?

Sheila Burns's email address is as****@****ktx.com

What schools did Sheila Burns attend?

Sheila Burns attended Immaculata University, Delaware Technical & Community College.

What skills is Sheila Burns known for?

Sheila Burns has skills like Change Control, Gmp, Gxp, Capa, Fda, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, Technology Transfer, Quality Auditing, Biotechnology, Trackwise.

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