Job Description
The primary purpose of the Laboratory Analyst is to analyze raw materials, in-process products, finished goods, and stability samples according to relevant specifications.
The QC Analyst shall perform most duties in the QC Laboratory. Key tasks and responsibilities include:
* Working under the direction of the Area Supervisor, adhering to company safety policies, cGMP, and cGLP guidelines.
* Receiving and logging samples into the laboratory.
* Analyzing raw materials, in-process products, finished goods, and stability samples associated with development products according to specifications.
* Performing analytical method validations and investigational testing as directed.
* Recording results in a timely and accurate manner.
* Achieving the Right First Time KPI for Analyst documentation.
* Reviewing coworkers'/analysts' documentation.
* Ensuring adherence to quality systems within the department on a daily basis.
* Properly labeling laboratory reagents and samples.
* Troubleshooting erroneous analytical data (involvement in lab investigation reports).
* Ensuring laboratory SOPs and specifications remain up-to-date and compliant.
* Providing training to other laboratory staff as requested and appropriate.
About the Role
* Minimum 2 years of HPLC experience.
* Able to troubleshoot, identify analytical issues, and implement corrective actions.
* Bachelor's degree in a science-related field.
* Critically reviewing analytical data and possessing excellent attention to detail are essential.
* Able to work effectively with internal and external key contacts.
* Experience working in a cGMP environment (HPRA and FDA approved) is desirable.