The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:
* Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
* Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
* Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
* Assisting as needed in audit by external agencies in answering questions related to NCs
* Performing other duties as required by Manufacturing Management Basic
Requirements
* Ability to communicate and collaborate with technical and management staff
* Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions
* Project Management experience
* Experience interacting with representatives of regulatory agencies
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR
* Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
* 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
* Detailed technical understanding of fill/finish oJob Description
The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:
* Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
* Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
* Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
* Assisting as needed in audit by external agencies in answering questions related to NCs
* Performing other duties as required by Manufacturing Management Basic
Requirements
* Ability to communicate and collaborate with technical and management staff
* Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions
* Project Management experience
* Experience interacting with representatives of regulatory agencies
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR
* Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
* 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
* Detailed technical understanding of fill/finish o
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical