Quality - Technical writer - Advent Global Solutions
Libertyville, IL 60048
About the Job
Job Description: MSAT Technical Writer, Cell Therapy Vector Support ,Support, Manufacturing Science and Technology (MSAT)
The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The MSAT Tech Writer:
- Compiles and interprets manufacturing process data to identify possible failure modes
- Learns complex cell biology concepts & applies them to root cause investigations
- Works independently and with Process Engineer(s) to understand different failure modes
- Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports
Education:
- BS in Bio/Chem Science/Engineering or related field
- Immunology education preferred
Experience:
Required experience:
" 3+ years relevant experience in drug product biopharmaceutical or equivalent industry
" Deviation writing
" cGMP/cGDP
" Ability to prioritize multiple investigations in order to meet deadlines
" Strong scientific and technical acumen including technical writing skills
Preferred experience:
" Quality management system
" Complex problem-solving skills, including root cause investigation
" Cross-functional collaboration with engineering and quality partners
" Biologics or cell therapy manufacturing
" Trained in Kepner Tregoe Problem Solving
Duties and Responsibilities:
" Facilitates deviation closure through working with quality partners and site quality systems
" Analyzes and summarizes manufacturing data to support root cause investigations
" Analyzes and summarizes characterization data to write root cause investigations
" Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause
" Writes technical and thorough investigation reports
Additional Job Requirements:
None
The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The MSAT Tech Writer:
- Compiles and interprets manufacturing process data to identify possible failure modes
- Learns complex cell biology concepts & applies them to root cause investigations
- Works independently and with Process Engineer(s) to understand different failure modes
- Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports
Education:
- BS in Bio/Chem Science/Engineering or related field
- Immunology education preferred
Experience:
Required experience:
" 3+ years relevant experience in drug product biopharmaceutical or equivalent industry
" Deviation writing
" cGMP/cGDP
" Ability to prioritize multiple investigations in order to meet deadlines
" Strong scientific and technical acumen including technical writing skills
Preferred experience:
" Quality management system
" Complex problem-solving skills, including root cause investigation
" Cross-functional collaboration with engineering and quality partners
" Biologics or cell therapy manufacturing
" Trained in Kepner Tregoe Problem Solving
Duties and Responsibilities:
" Facilitates deviation closure through working with quality partners and site quality systems
" Analyzes and summarizes manufacturing data to support root cause investigations
" Analyzes and summarizes characterization data to write root cause investigations
" Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause
" Writes technical and thorough investigation reports
Additional Job Requirements:
None
Source : Advent Global Solutions