MSAT Technical Writer - Artech LLC

Must Have List:
More than 3 years of experience with the following:
" Relevant experience in drug product biopharmaceutical or equivalent industry
" Investigation
" Deviation writing
" cGMP/cGDP
" Strong scientific and technical acumen including technical writing skills.
" BS in Bio/Chem Science/Engineering or related field. Immunology education preferred.

Job Description
The focus of the MSAT Technical Writer is to investigate and write root cause analysis 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

Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: krysty@alphaconsulting.com

ALPHA s REQUIREMENT #24-14140
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE