Technical Writer

Bachem AG•Vista, CA

16d•$61,171 - $84,110

About The Position

The Technical Writer I will prepare cGMP documentation, including protocols, reports, studies, Failure Mode and Effect Analyses (FMEAs), memos, forms, specifications, qualifications, change controls, deviations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), and Master Batch Production Records (MBPRs).

Requirements

Bachelor's Degree BS Degree in Chemistry or related field
Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment
1 year of technical writing experience
Experience with peptide manufacturing and associated analytical methods
Experience with cGMP manufacturing and documentation standards (Preferred)
Understanding of in-process analytical methods (e.g. HPLC)
Comfortable working around hazardous materials and chemicals
Excellent written and oral communication skills
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one’s time
Ability to communicate effectively and function well in a team environment

Nice To Haves

Experience with cGMP manufacturing and documentation standards (Preferred)

Responsibilities

Write and revise documentation, such as protocols, reports, SOPs and associated forms, and MBPRs.
Review and complete all documentation following cGMP guidelines
Ensure collaboration between all applicable departments, such as Production, Facilities, Materials Management, QA and QC
Adhere to manufacturing schedules and timelines
Participate in the validation of products and processes
Participate in project meetings with subject material experts