Kristopher Stavely

Kristopher Stavely Email and Phone Number

Quality / Regulatory Affairs @ Product Development Partners LLC
Kristopher Stavely's Location
St Petersburg, Florida, United States, United States
Kristopher Stavely's Contact Details

Kristopher Stavely work email

Kristopher Stavely personal email

n/a
About Kristopher Stavely

Pharmaceutical Regulatory Professional in the Tampa/St Petersburg Area. Specifically, pharmaceutical and medical device manufacturing quality control and assurance. My current role includes quality control , document control, regulatory affairs, ECTD filing, pharmaceutical stability, outsourced product control, and Six Sigma/statistical process controls.I also enjoy a side career in graphic/web-design as well as participation in various volunteer/charity groups.Specialties: Six Sigma Green Belt, environmental chamber control and mapping, laboratory equipment and method validation, experience with Corrective Action/Preventative Action, document control, annual review, and laboratory investigations.

Kristopher Stavely's Current Company Details
Product Development Partners LLC

Product Development Partners Llc

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Quality / Regulatory Affairs
Kristopher Stavely Work Experience Details
  • Product Development Partners Llc
    Director Of Regulatory Affairs
    Product Development Partners Llc Jan 2022 - Present
    Tampa, Florida, United States
  • Product Development Partners Llc
    Quality Control/Document Control Supervisor
    Product Development Partners Llc Jun 2020 - Feb 2022
    Tampa, Florida, United States
  • Product Development Partners Llc
    Assistant Scientist Ii
    Product Development Partners Llc Oct 2009 - Jun 2020
  • El Coyote Design
    Owner
    El Coyote Design Jan 2006 - Present
    Graphic Design business serving the local community, providing graphics, design work, web design, and contract printing services through local printing partners.
  • Smith & Nephew
    Product Control Specialist
    Smith & Nephew Jun 2009 - Oct 2009
    Position responsible for the coordination of Stability information between Smith & Nephew Wound Management and outsourced manufacturing partners, ensuring regulatory compliance and continued monitoring of OTC drug and medical Device products. Also responsible for Annual OTC review, CAPA, statistical data analysis and data trending, product release, and coordination between quality and regulatory departments.
  • Smith & Nephew
    Stability Coordinator
    Smith & Nephew May 2005 - Jun 2009
    Coordination of the stability program. Monitoring shelf life, determining expiration, and analyzing trends related to the manufacture and storage of OTC drug products and Medical Devices. Bring expertise with the associated products to relevant project teams, acting as quality representative for various product lines.
  • Smith & Nephew
    Chemist/Microbiologist
    Smith & Nephew May 2003 - May 2005
    Analytical Chemist position responsible for day to day release of finished product, raw material, and in process samples. Also responsible for analysis and monitoring within the microbiological including raw material, finished product, and environmental surface, water, and air sampling. Review of Sterilization of medical device products via Gamma, E-beam, and EtO gas including coordination of Dose audits as well as bioburden/sterility testing.
  • King Pharmaceuticals
    Chemist
    King Pharmaceuticals 2000 - 2003
    Analytical Chemist Position testing finished product Pharmaceuticals as well as incoming raw materials.

Kristopher Stavely Skills

Quality System Six Sigma V&v Hplc Pharmaceutical Industry Regulatory Affairs Document Management Glp Validation Capa Medical Devices Fda Quality Assurance Sop Gmp Iso 13485

Kristopher Stavely Education Details

Frequently Asked Questions about Kristopher Stavely

What company does Kristopher Stavely work for?

Kristopher Stavely works for Product Development Partners Llc

What is Kristopher Stavely's role at the current company?

Kristopher Stavely's current role is Quality / Regulatory Affairs.

What is Kristopher Stavely's email address?

Kristopher Stavely's email address is kr****@****vely.us

What schools did Kristopher Stavely attend?

Kristopher Stavely attended Fort Lewis College.

What skills is Kristopher Stavely known for?

Kristopher Stavely has skills like Quality System, Six Sigma, V&v, Hplc, Pharmaceutical Industry, Regulatory Affairs, Document Management, Glp, Validation, Capa, Medical Devices, Fda.

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