Quality Assurance Specialist
The role of Quality Assurance Specialist is to oversee the daily laboratory testing of raw materials, in-process and finished products. This position involves providing support for environmental testing, validation, stability, and other various laboratory and production testing.
This opportunity allows an individual to contribute to the success of a new facility in a start-up environment. Experience in a regulated environment and EMPOWER 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 minimise downtime.
* 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 cGMPs
Ideal Candidate:
* Minimum of a Bachelor's degree in Chemistry or related scientific field.
* 4+ years of related experience.
* Knowledge of analytical instrumentation (GC, HPLC, UV-VIS, etc.)
* 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 standardised situations.
* Proficiency with Microsoft Word, Excel, and Access.
Contact us for a confidential discussion and more information on this role.