A brief overview

The Technical Writer 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).

What you will do

• 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

Qualifications

• Bachelor's 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 (preferred)
• 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

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.

Base Hourly Range:

Tech Writer I: $25.87 - $35.57 (1-3 years exp)

Tech Writer II: $29.34 - $40.34 (3-5 years exp)

Tech Writer III: $35.52 - $48.83 (5-7 years exp)

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status