Sr QC Development and Technical Analyst

Overview

Core

Hours:

Monday - Friday, 8am-5pm

Purpose and Scope

The Senior QC Development and Technical Analyst is a technical leader within QC with a primary role in supporting the life cycle of chemistry methods. Responsibilities include supporting Analytical Development in method development, validation and transfer activities, performing suitability testing on compendial methods, and supporting ongoing testing for all non-commercial stability testing. Function as SME for transferred methods and support training of QC personnel.

Support QC management in ensuring all QC activities which will be transferred to QC remain compliant with cGMP requirements. Function as a QC leader in continuous improvement and support the business needs of the department. Perform complex testing of raw materials, intermediate and finished product testing as needed.

Essential Duties & Responsibilities

• Function as a subject matter expert for the QC department consistently demonstrating the professional expectations of the department. This includes adherence to compliance, time management, commitment to collaboration with all personnel, effective communication both written and verbal, and embrace challenges with curiosity and enthusiasm.
• Expertise in performing analyses on a variety of samples using advanced preparation techniques analysis methods and instrumentation.
• Provide mentorship to QC analysts in all aspects of analyses performed within the QC chemistry laboratory including but not limited to documentation, procedures, regulations, technical understanding and method troubleshooting best practices.
• Accountable for proper use, care, maintenance, and troubleshooting of instrumentation.
• Requires the ability to write clear and effective scientific documents and requires the ability to review complex and technical documents.
• Performs high level method transfers and leads the department in the evaluation and implementation of new technologies. Collaboration with Analytical Development during method development requiring effective communication of commercial QC challenges to ensure validated methods are compatible with commercial testing, previous CAPAs and regulations.
• Support investigations, provide technical guidance, and perform investigational testing.
• Provide scientific recommendations to management/technical writers regarding QC procedures requiring the ability to collect recommendations, identify essential steps, ensure the appropriate changes are made, and serve as a technical reviewer for document updates to ensure correct changes are made with scientifically sound justification.
• Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner and is a productive member of the department. Contributes to a highly productive environment by avoiding distractions.
• Support adherence to department budget by identifying alternative cost-saving and compliant materials and equipment during the method development process, where appropriate.
• Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results. Understand method development principles (accuracy, robustness, precision, etc.) and provide technical expertise to determine root cause of aberrant method transfer results.
• Leads implementation of change and demonstrate leadership aptitude in technical functions.
• Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Understands and processes complex information and exercises sound judgment, considering the situation, the issues, the key players and the levels of authority involved. Proposes courses of action that further the objectives, priorities, and vision of the organization
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Responsible for acting as a technical reviewer for document updates to ensure changes that are made are justified and scientifically sound.
• Lead with a compliance mindset.
• Keeps up to date with regulatory guidelines and their application to the laboratory functions.
• Perform additional duties as assigned.

Knowledge, Skills & Abilities

• Advanced knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
• Advanced knowledge in the use of USP, NF and other compendia.
• Highly proficient use of analytical laboratory instruments such as HPLC, FTIR, FTNIR, GPC, GC, and UV-Vis spectrophotometers.
• Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Excellent written and oral communication skills.
• Ability to interpret, understand and follow analytical procedures and…