Daniel J. Sedlak

About Daniel J. Sedlak

I worked as an analytical Chemist for 10+ years and transitioned to Quality Assurance and…

Experience

1. Senior Quality Engineer

   Biogen

   Oct 2020 — Present · Research Triangle Park, NC, US

   Reviews GMP raw data, validation protocols, and GMP procedures and identifies gaps in existing Quality systems and proposes solutions to site management Assists in the development and implementation of Global Quality Systems, leading site and global initiatives and provides oversight to the proper administration and adherence to all policies and procedures Abides by all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers and coordination of investigations Performs reviews of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents as well as facility and equipment controls and release during shutdown, construction, product changeover Provides cGMP guidance and quality support of Manufacturing on the floor issues, including assistance with deviation initiation Reviews PM/CM work orders as applicable to cGMP systems. Proactively identifies resolutions of technical and compliance issues or gaps Performs QA review of alarm assessments for cGMP equipment Supports internal and external inspections, assesses and approves discrepancies from site, corporate, and regulatory guidance Supports the manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies

Skills

• Wet Chemistry
• Hplc
• Ir