
Senior Laboratory Analyst with cGMP Expertise
3 days ago
The Akhai Group is seeking a highly motivated Senior Laboratory Analyst with cGMP Expertise to join our team.
In this role, you will be responsible for overseeing routine testing of raw materials using HPLC and maintaining laboratory records.
Key Responsibilities:- Assisting in performing validations and reviewing test method results for conformity to specification
- Reporting on quality discrepancies and maintaining critical operating parameters for laboratory equipment and instrumentation
- Collaborating with Contract Test Laboratories and other outside entities
- Coordinating receipt, tracking, storage, shipment, and distribution of Stability, Raw Material, and In-process QC samples
A minimum of 6 years of Pharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant.
Essential Skills Include:
- Superb communications—both written and oral skills
- ISO exposure and familiarity required; ISO 9001:2015
- Utilizes strong organizational, interpersonal, and communication skills to plan and accomplish goals
- Analytical Instrumentation Knowledge and working command: HPLC/UPLC, Luminometers, Microplate Readers, and/OR UV/VIS
- Candidates with direct experience in Stability and Raw Materials
- Bachelor's degree required; preference given to candidates with advanced degrees and degrees in Chemistry or a biological science
- Thorough knowledge of cGMPs, ICH, USP/EP/JP, and global regulatory requirements
- Knowledge of test procedures and instruments for stability and raw material testing program
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