Analytical Chemist Technical Writer
Location : Philadelphia PA US 19154
Job Type : Direct
Reference Code : 20265-AB1
Compensation : 80000.00 - 95000.00 USD/YEAR
Start Date : 08/07/2020
Hours : Full Time
Required Years of Experience : 3
Required Education : MS Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for an Analytical Chemist to serve as a Technical Writer to generate, review, and modify documentation for regulatory agency ANDA / NDA submissions including SOPs, technical packages, specifications, test methods, vendor qualification documents, and DMFs. Position is with a growing Philadelphia specialty pharmaceutical company.
- Review USP/NF supplements, PF, and European Pharmacopeia to provide and implement proposed recommendations.
- Develop method validation / qualification / stability / transfer protocols and reports.
- Ensure CGMP compliance related to documentation and regulatory filing are completed, while training and developing staff in CGMP requirements.
- Recommend appropriate quality systems and procedures.
- Address deviations and investigations arising from OOS, OOT and other compliance-related situations by generating reports, authoring CAPAs, and conducting root cause impact analysis.
Required Qualifications :
- MS / PhD Analytical Chemistry or similar
- Minimum 3 years pharmaceutical experience in analytical chemistry.
- Strong skills and hands-on experience in HPLC, GC, Dissolution, UV/VIS, wet chemistry techniques common to the industry.
- Strong oral and written communication skills are required.
- Experience with Microsoft Office (Word, Excel and PowerPoint) and Documentum based document storage systems.
- Knowledge and experience with regulatory requirements including ICH, FDA and DEA.
- Position includes 5-10% bonus on salary.
Contact: Allan Berman