The Quality Control (QC) Sr. Analyst, Analytical Science & Technology is responsible for ensuring that all functions within AS&T are operating in a compliant manner. The functions within AS&T include method transfer, method validation, instrument maintenance and qualification, data review, laboratory investigation support, analytical method troubleshooting and QC project support. Sr. Analysts are assigned areas within the AS&T team based on their functional mastery and experience. The QC Sr. Analyst will apply in-depth knowledge of relevant guidance/regulatory documents, perform and lead routine and non-routine testing activities to include analytical method validations, analytical method transfers, product/process investigations, ensuring required quality and safety standards are being met for GCBT products and processes. The AS&T Sr. Analyst will be responsible for planning of his/her respective projects and assignments, providing technical support, and interfacing with QC Microbiologists and Chemistry (QC Operations) analysts. This position is expected to maintain operational and GMP readiness of the QC areas. Based on the level of this position, the individual in the Senior Analyst role is expected to participate in more complex projects including QC studies and to develop mastery of a diverse number of analytical techniques and fluency with analytical technologies. In addition, the Sr. Analyst AS&T will participate in lab operational excellence initiatives and various lab quality systems (deviations, change controls, lab investigations) with little to no supervision. The Sr. Analyst may be asked to take on a lead role for the QC organization on these projects. This position is expected to act as a role model for junior staff in the various QC areas.
Key Duties and Responsibilities
- As a senior analyst, leads, implements and reports on site AS&T requirements / programs / projects in compliance with GMP and internal requirements.
- Supports planning, execution and reporting of stability programs, validation / qualification programs, method transfers, and other AS&T related operational activities
- Supports analytical trouble shooting as needed, e.g. as part of out of specification investigations, deviations or complaints. Drives appropriate remediation plans to avoid recurrence
- Interprets the analytical data, analyzes trends and provides conclusions (e.g. shelf life assessment, storage conditions etc.)
Planning - Ensure laboratory supplies, instrumentation and equipment are available to meet test schedules.
- Plan and execute testing schedules with no supervision; coordinates daily workflow needs of the lab; Acts as a Supervisor designee at the request of the QC Manager (all issues excluding personnel matters)
- Recognize lab supply needs and facilitates ordering
Technical - To perform testing activities, ensuring required quality standards are being met for our products.
- Execute analytical method development and validation
- Perform non-routine testing to support special projects
- Execute analytical method transfers as the receiving lab and the transferring lab
- Write/review/approve analytical method validation protocol and technical reports
- Collect, calculate, interpret and trend results
- Write SOPs related to testing programs, laboratory operations and/or equipment operation
- Participate in root cause analysis; lead and write laboratory investigations
- Perform and review equipment calibration and maintenance; instrument advocate and subject matter expert
- Evaluate novel technology for laboratory/manufacturing application
- Identify appropriate lab instrumentation purchases; perform qualification/validation
- Conduct peer review and approval of data collected by co-workers
- Lead lab initiatives or programs and train analysts. Utilize change control systems.
- Perform statistical analysis
- Represent the laboratory as the Subject Matter Expert in all major test disciplines and processes
- Track and report laboratory performance metrics
- Facilitate and lead laboratory investigations; interface with QA in the execution of product quality investigations.
Team - Cooperate and support co-workers to enhance overall capability the organization
- Lead problem solving and troubleshooting of laboratory issues and methodology
- Contributes to departmental meetings; provides technical insight and presentations
- Supervisor Designee at the request and designation of the QC Manager
- Demonstrates overtime flexibility as required during start-up and initial commercial operations
Interfaces - Coordinate/support other departments to ensure smooth execution of work.
- Excellent communication both verbal and written skills concerning testing and sampling scheduling with other departments and external labs/vendors
- Professional and skilled interface with auditors
- Work is performed under general direction with little supervision. Participates in determining objectives of assignments. Plans scheduled and arranges own activities in accomplishing objectives of the laboratory department. Work will be reviewed upon completion for adequacy in meeting objectives. This role may be responsible for reviewing the work of more junior analysts and providing training on analytical methods and techniques.
- Perform all lab functions in compliance with cGMP. The Sr. Analyst must have a mastery of a broad range of techniques in order to support the Analytical Science & Technology team.
- Perform troubleshooting of test methods as required. Participate in training technicians and analysts.
- Support and facilitate the continued implementation and maintenance of the lab data integrity program; provide DI training and coaching to team.
- Support the implementation of Laboratory Information Management System (LIMS).
- Collaborate with QC Manager to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
- Leads improvement areas, develops lab procedures and related processes.
- Minimum of a bachelor's degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology) and experience in a Biotech or pharmaceutical QC Laboratory required. GMP experience required.
- A subject matter expert level knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
- Related experience: 6 to 8 years of working experience in a GMP laboratory role. Minimum 5 years within QC (method development, method validation, stability testing).
- Expert knowledge of USP, Ph. Eur. Pharmacopeia.
- Advanced to expert knowledge of cGMPs, ICHG guidelines, good documentation practices and data integrity requirements. Experience in risk management and project management.
- Proven track record with regulatory inspections (Health Canada/FDA/EMA or other)