Technical Writer (Quality)

Job Description
On-Board Services is hiring a Technical Writer in Bothell, WA!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type:12 Month Contract
Job Location: Bothell, WA
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $54.16- $55.76
Summary:
The focus of the MSAT Technical Writer is to investigate and write root cause analyses of in-process and end-of-process testing results outside of the specified range during and after drug product manufacturing. 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:
•1+ years relevant experience in drug product biopharmaceutical or equivalent industry
•cGMP/cGDP
•Ability to prioritize multiple investigations in order to meet deadlines
•Strong scientific and technical acumen including technical writing skills
Preferred experience:
•Deviation writing
•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 Kepner Tregoe Problem Solving to identify root cause
•Writes technical and thorough investigation reports
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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INDOJ