Stephanie M. Email and Phone Number
Able to learn quickly as well as efficiently. Driven to constantly make improvements and learn from new experiences and past mistakes. Experience in USP and FDA methodology and validation. Highly motivated, quality oriented validation specialist in cGMP and laboratory environments. Skilled in writing, executing, and summarizing validation protocols and reports. Experience in writing numerous documents required for submissions of various products to different markets around the world.
Csl Seqirus
View- Website:
- csl.com.au
- Employees:
- 14897
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Validation Manager, ProcessCsl Seqirus Jan 2023 - PresentHolly Springs, North Carolina, United States
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Validation Specialist Iii - Process ValidationSeqirus Jan 2019 - Feb 2023Holly Springs, Nc-Current SME for shipping validation program in Holly Springs, aided in the global harmonization of Seqirus SV program and routinely seek to improve efforts.-Extensive knowledge in cleaning validation. Routinely author and execute CV protocols and support optimization of cleaning processes.-Continuous support for aseptic validation program (formulation and filling).-Experience in regulatory audits.
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Validation Specialist IiMangan Inc. Jul 2013 - Jan 2019Cary, NcContract valdiation specialist for various pharma companies. Experience consists of but not limited to: equipment validation, computer validation, TCU revalidations, cleaning validation, authoring various regulatory documents, as well as IOQs, SOPs, RA's, VMP's, etc. -
Qc Microbiology Analyst IiNovartis Vaccines And Diagnostics Aug 2010 - Jul 2013Holly Springs, Nc-Authored and executed various method verifications for products in sterility, endotoxin, and bioburden testing. -LIMS super-user for QC Micro as well as certified LIMS trainer for QC-Performed environmental monitoring for PQ and routine processes.-Certified trainer for all aspects of EM-Performed routine in-process testing of Bi's, visual sterility, sterility, growth promotion, bioburden, endoxtoxin, TOC, and conductivity. -
Qc AnalystHospira May 2007 - Aug 2010Clayton, NcPerformed final product release testing in both QC Chemistry and QC Microbiology
Stephanie M. Education Details
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Pharmaceutical Sciences
Frequently Asked Questions about Stephanie M.
What company does Stephanie M. work for?
Stephanie M. works for Csl Seqirus
What is Stephanie M.'s role at the current company?
Stephanie M.'s current role is Validation Manager - Process Validation at Seqirus.
What schools did Stephanie M. attend?
Stephanie M. attended Campbell University.
Who are Stephanie M.'s colleagues?
Stephanie M.'s colleagues are Satoshi Akiyama, David Rusec, Michael Massaro, Rohit Karki, Jonah To, Aishah Kadher, Tawny King.
Not the Stephanie M. you were looking for?
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Stephanie M.
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Stephanie Holman, M.Ed
Washington Dc-Baltimore Area3park.edu, amazon.com, metrostarsystems.com -
Stephanie M.
Compliance Analyst | Regulatory Knowledge | Risk Management | Critical Thinking | Policies &Procedures | Training | BankingMinneapolis, Mn -
Stephanie Dwelly
✴️ Bestselling Author ✴️ Certified Resume Writer & Online Profile Expert ▶️ Using The Power Of Story To Drive Personal & Professional GrowthCincinnati Metropolitan Area
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