The Scientist II, QC Analytical is responsible for identifying basic technical issues, atypical results, or malfunctions in methodologies and contributes to resolving them. This position provides technical support for routine testing and performs physical and chemical analyses of samples, products, and materials. It ensures compliance with regulatory guidelines in notebooks and reports, completes projects within deadlines and budget limits, performs mathematical calculations, interprets results, records observations, and assists in audits and investigations. The primary responsibility is the technical transfer and validation of methods to support quality control testing. Additionally, the incumbent provides training and guidance to junior staff members.
Key Responsibilities:
Accurately generate data using validated test methods and SOPs in a cGMP environment.
Demonstrate technical proficiency in wet chemical techniques and instrumentation such as Infrared Spectroscopy, UV/Visible Spectroscopy, Gas Chromatography, HPLC, UHPLC, Atomic Absorption Spectroscopy, Dissolution apparatus, and compendial testing (USP, EP, JP).
Initiate proper documentation upon detecting deviations or out-of-specification results and complete Trackwise write-ups accordingly.
Participate in special projects, including testing, data compilation, trending, and report generation.
Collaborate with vendors for instrument maintenance documentation and evaluate third-party or vendor methods for in-house qualification.
Understand and execute protocols, providing information to draft and qualify in-house test standards and methods.
Revise SOPs and methods as necessary, with potential involvement in drafting protocols, SOPs, or methods.
Troubleshoot instrument and method-related issues.
Conduct investigative testing when required.
Train other scientists in various methodologies.
Analyze data, maintain accurate and detailed records, and review lab notebooks for compliance with methods and specifications.
Maintain training logs to comply with SOP requirements.
Ensure adherence to safety regulations in the laboratory.
Comply with all company policies and demonstrate flexibility in work schedule.
Perform other duties as assigned.
Qualifications:
Bachelor's degree in Chemistry, Biology, or a related science is required.
2-5 years of experience in a cGMP analytical laboratory.