The QC Analyst I position is responsible for daily laboratory testing of raw materials, in process and finished products. In addition, this position is responsible for providing support for environmental testing, validation, stability and other various laboratory and production testing.
- Perform chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.
- Assist in sampling of raw materials upon receipt, when needed. Aid in maintaining quick turnaround time of raw material release.
- Familiar with Quality GMP documentation (hard copy and electronic) of testing results and assurance of laboratory data integrity.
- Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
- Experience with USP interpretation and testing.
- Support QC audit readiness with understanding of FDA and ISO regulations and requirements.
- Support on-time performance in the QC lab against the Production and laboratory schedules.
- Assist with maintenance and troubleshooting of QC lab equipment to minimize downtime.
- Assist with OOS investigations.
- Maintain a safe, clean, and organized environment (5S) for all QC areas.
- Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
- Troubleshooting laboratory instrumentation and administer simple repairs as needed
- Review batch records to ensure they are compliant with SOPs, WIs, and cGMPs
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices
- Any additional functions as assigned by the Laboratory Manager
- Bachelor’s degree in Chemistry or related scientific field
- Bachelor’s degree in Chemistry or related scientific field 1+ years related experience (preferred)