Job Purpose: This 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.
Key Responsibilities: Adhering to all Quality and Safety requirements on site and supporting Quality and Safety initiatives as required 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 out of specification investigations.
Maintain a safe, clean, and organized environment (5 S) 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.
Review batch records to ensure they are compliant with SOPs, WIs, and c GMPs Follow all SOPs and Safety Guidelines to ensure compliance with a c GMP environment and Safety Practices.
Any additional functions as assigned by the Laboratory Lead Education and Experience: Minimum of a Bachelors degree in Chemistry or related scientific field Experience working in an ISO or FDA regulated environment preferred Familiarity with Empower Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.
Ability to deal with problems involving several concrete variables in standardized situations Proficiency with Microsoft Word, Excel, and Access.