Seeking 3 Technical Writers with 5-8 years' GMP lab experience, specializing in SOP creation and review.
TOP SKILLS:
- GMP laboratory environment expertise
- 5+ years' experience in SOP documentation
- Familiarity with Veeva EDMS or similar systems
- ERP and SAP experience preferred
- Strong cross-functional communication and customer service skills
KEY RESPONSIBILITIES:
- Write and revise SOPs for GMP Analytical and Microbiology labs
- Interview subject matter experts and translate info into clear instructions
- Manage document workflows using EDMS, SharePoint, and MS tools
- Schedule and facilitate cross-functional reviews
- Lead SOP improvements and ensure compliance with regulations
- Maintain knowledge of GMP guidelines and regulations
- Independently manage tasks and communicate progress effectively
REQUIREMENTS:
- Proven ability to handle deadlines and prioritize
- Excellent technical writing, attention to detail, and system proficiency
- Experience with microbiology testing a plus
- Strong skills in MS Word, SharePoint, MS Teams, and EDMS
- Ability to conduct video calls and collaborate remotely for 4-6 hours daily.