Bachem is a leading company specializing in the development and manufacture of peptides and oligonucleotides. The QA Specialist II performs day-to-day activities of the QA department to ensure drug substances comply with FDA and international regulatory requirements.
Requirements
- Bachelor's degree in a science related field
- 3-5 years' experience in Quality Assurance and/or Quality Control
- 3-5 years' experience in internal auditing as well as working with regulatory agencies
- Ability to review scans of BPRs and chromatograms with high accuracy
- Knowledge of cGMP and FDA regulations and guidance(s)
- Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint
- Ability to communicate in a proactive and solution-focused manner
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to work independently and manage one's time
- Ability to troubleshoot and resolve problems
Benefits
- Annual performance bonus
- 401(k) plan with employer contribution
- Comprehensive Medical/Dental/Vision coverage
- Paid vacation, personal and sick days