Job Description:
* The Senior Laboratory Quality Assurance Specialist is responsible for ensuring the quality of laboratory testing and analysis.
* This role provides support for environmental testing, validation, stability, and other various laboratory and production testing.
* Experience in a regulated environment is preferred.
Main Responsibilities:
* 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.
* Employ sound and compliant laboratory techniques and logic per industry standards (FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
* Troubleshoot laboratory instrumentation.
* Review batch records to ensure they are compliant with SOPs, WIs, and cGMPs
* Any additional functions as assigned by the Laboratory Lead.
Requirements:
* Background in chemistry or related field.
* Proven experience in laboratory testing and analysis.
* Excellent knowledge of Quality GMP principles and regulations.
* Strong communication and teamwork skills.