Actalent is Hiring a QC Scientist Reviewer

Job Description

The role of the Data Reviewer involves meticulous examination of all analytical reports and raw and electronic data from CMC, including materials and equipment calibration. The position is crucial in ensuring that tests are within specified limits, and requires coordination with the CMC Manager and QA for appropriate actions when necessary.

Responsibilities

• Ensure analytical data meets company standards and regulatory requirements.
• Review test results and raw data for various materials and stability samples, including assays, chromatographic purity, content uniformity, particle size distribution, density, and water determination.
• Check laboratory notebooks and associated documents for correctness and verify all reagents, standards, and equipment used.
• Review raw data for audit trails and instrument logs on cGMP instrumentation and equipment.
• Review validation and method optimization reports.
• Ensure chemists follow SOPs and cGMP regulations and use correct methods for each product.
• Promptly review notebooks and sign off on all analytical test results and reports.
• Analyze and interpret results in written and oral formats.
• Work with analysts for document corrections and provide guidance on laboratory notebook documentation requirements.
• Follow SOPs and Safety Guidelines to ensure compliance with cGMP environment and Safety Practices.
• Provide support during regulatory and internal audits.
• Review Laboratory Incidents, OOS, OOT, and OOE investigations.
• Perform additional tasks as assigned by the QA supervisor.

Essential Skills

• Bachelor's degree in Chemistry or related field.
• 4+ years of related experience in pharmaceutical analysis.
• Experience with various analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, Dissolution, Raw Materials, etc.
• Understanding of SOPs, USP/NF procedures, and requirements.
• Previous cGMP/regulatory experience preferred.

Additional Skills & Qualifications

• Proficiency in chemistry, quality control, data review, and quality assurance.
• Knowledge of LC, GC, CAPA, and Change Controls.

Work Environment

This position is generally performed in a GMP lab environment and office space. Physical requirements include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. Occasionally, bending, kneeling, crouching, stooping, and crawling may be required. The role may require lifting up to 15 pounds occasionally.