QC Scientist Reviewer Position Available In Broward, Florida
Tallo's Job Summary: Actalent is looking to hire a team of QC Scientist Reviewers who will be responsible for reviewing analytical reports and data from CMC, ensuring compliance with company standards and regulatory requirements. The role involves analyzing test results, validating reports, and providing guidance on laboratory documentation. Candidates should have a Bachelor's degree in Chemistry, 4+ years of pharmaceutical analysis experience, and proficiency in quality control practices. This position requires expertise in data review, familiarity with analytical instrumentation such as HPLC and GC, and knowledge of CAPA and Change Controls. The work environment includes standing, walking, and sitting in a GMP lab and office setting.
Job Description
Actalent is Hiring a Team of QC Scientist Reviewers! Job Description The Quality Control Analyst position involves reviewing all analytical reports and raw and electronic data from CMC, including various materials and equipment calibration. The role requires informing the CMC Manager and QA when tests are not within specified limits to take appropriate actions. 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 Proficiency in chemistry and quality control. Expertise in data review and record analysis. Knowledge of quality assurance practices. Experience with LC and GC instrumentation. Understanding of CAPA and Change Controls. Additional Skills & Qualifications 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. Understanding of SOPs, USP/NF procedures, and requirements. Previous cGMP/regulatory experience is preferred. Work Environment The position generally involves 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 position may require lifting up to 15 pounds occasionally and is generally performed in an office environment. Work is conducted in a GMP lab environment and office space.
