The Sr. QC Analyst is responsible for managing/carrying out analytical testing on inactive and active ingredients, packaging components, and in-process and stability samples. Chemist will be able to perform analytical analysis. And possess theoretical knowledge of the microbiological methodologies.
The Sr. QC Analyst will administer activities such as planning/scheduling all laboratory testing workloads to meet objectives of Production Operations; ensuring cGMP/Regulatory/Safety compliance for laboratory testing, documentation, investigations, instrumentation/equipment, and training; coaching and developing staff. He/she will draft or contribute to all QC formal laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation including worksheets, and laboratory notebooks. He/she represents QC on cross-functional department teams. All of the activities mentioned above performed with minimal periodic supervision.
GENERAL SCIENTIST REQUIREMENTS
Sr. QC Analysts are required to work with minimal direction and supervision.
The Sr. QC Analyst will be able to accurately records, summarizes, and reviews laboratory data/documentation.
He/she drafts or contributes to all QC formal laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation including LIMS, worksheets, and laboratory notebooks.
The Sr. QC Analyst will be able to conduct laboratory investigations, troubleshoot instrumentation, and method related problems.
Maintain accurate records of tests performed and corresponding results in research notebooks, worksheets or validated computer systems. Perform required calculations and recognize and record unexpected laboratory developments. Develop hypotheses for the occurrence of problems and propose alternative courses of action.
Trend routine data and evaluate impact on manufacturing processes. Prepare formal reports by organizing results in a comprehensive tabular or graphic form. Provide data summaries to appropriate manufacturing personnel.
Review data produced by analysts. Periodically summarize status and progress of assigned activities for individual work, as well as that performed by other analysts, when requested by supervisor. Assume responsibility for project management as assigned by supervisor.
contribute to all formal laboratory documentation including, test methods, standard operating procedures (SOPs), procedural guidelines, and chemistry, microbiology, manufacturing and controls sections of IND’s and NDA’s.
Sr. QC Analyst will work on problems from a diverse scope. Represent department and provide interface with personnel from other departments within /Baltimore, Raleigh, and Eisai Co. Ltd., as well as external partners and companies.
Assist with managing QC staff and projects to achieve the goals and objectives of Production Operations and Quality Control. This includes planning/scheduling laboratory workloads, as well as training, coaching, and assisting managing performance of staff members.
Review or prepare documentation of all laboratory work (e.g., test results, investigations, instrumentation/equipment preventative maintenance and calibration) in accordance with cGMP, cGLP, or SOPs, as appropriate. Ensure all laboratory work is conducted in compliance with applicable safety and environmental regulations.
Perform quantitative and qualitative analysis on raw materials, active pharmaceutical ingredients (API), packaging components, in-process materials, and finished product using various instrumental techniques, including but not limited to, HPLC, GC, GPC, and FTIR.
Drive investigations as the lead investigator and assures CAPA’s are completed properly and on-time
Represent QC at departmental meetings and on cross-functional department teams involving Eisai/RTP, Eisai Company Ltd., and external partners and companies. (Includes travel, as needed, to support business objectives.) Subject matter expert for required regulatory audit tours.
Periodically summarize status and progress of assigned activities as requested by supervisor.
Recognize unexpected laboratory results such as aberrant, out of trend result, or Out of Specification results. Conduct appropriate laboratory investigations and prepare reports
Troubleshoot instrumentation and method related problems of moderate scope. Develop hypotheses for the occurrence of problems and propose alternative courses of action
Represent QC at departmental meetings and on cross-functional department teams involving Eisai-Baltimore, ECL, and external partners and companies
Foster positive and productive work environment to meet testing and business needs of
Production Operations for commercial and/or new products.
Organize and manage information required to meet FDA regulatory and cGMP
Provide sound scientific process to problem analysis and decision-making in accordance
with cGMP compliance standards.
Assist with providing budget recommendations consistent with QC business needs.
Assist with purchase of capital instrumentation/equipment and laboratory supplies needed for day-to-day operations.
M. S. or Bachelors in Chemistry/Biology or equivalent discipline, with appropriate experience (Typically 8+ years), OR Associate degree or High School Diploma with appropriate equivalent experience (Typically 10 + years)
Extensive knowledge and demonstrated proficiency in pharmaceutical analysis and analytical techniques. Experience with variety of instrumental and wet chemical methods, including trouble-shooting laboratory instrumentation.
Experience with problem-solving, especially for handling out of specification data.
Knowledge of cGMPs and laboratory safety.
Strong interpersonal communication skills.
Critical thinking with ability to identify issues requiring further attention and ability to initiate and facilitate resolution of those issues.
DESIRED, BUT NOT ESSENTIAL QUALIFICATIONS
Biologic experience & understanding of large molecule biologic testing would be helpful. Understanding of Subculturing, Microbial ID Testing, Bacterial Endotoxin Testing, Bioburden Testing and Sterility Testing.
Experience with method validation and technical transfer activities. Experience in methods development and validation desirable and knowledge of USP Drug Release testing desirable
Knowledge of stability requirements for supporting investigational and commercial products.
Experience with commercial/start-up operations.
Demonstrated ability to work independently with minimal supervision.