The Quality Control AS&T Supervisor 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. This role is responsible for leading a team of Sr. Analysts who are assigned areas within the AS&T team based on their functional mastery and experience. The QC AS&T Supervisor 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 QC AS&T Supervisor is responsible for the 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 QC AS&T Supervisory 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 Supervisor, QC 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 Supervisor, QC AS&T 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.
The Challenges of the job…
Your key duties and responsibilities include:
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.)
Ensures laboratory supplies, instrumentation and equipment are available to meet test schedules.
Plans and executes testing schedules with no supervision; coordinates daily workflow needs of the lab; Acts as a Supervisor designee at the request of the QC Director (all issues excluding personnel matters)
Recognizes lab supply needs in advance and facilitates ordering by the AS&T Team.
Executes analytical method development and validation; executes analytical method transfers as the receiving lab and the transferring lab
Supervises a team of scientific professional in order to write/review/approve analytical method validation protocol and technical reports
Collects, calculates, interprets and trends results
Writes SOPs related to testing programs, laboratory operations and/or equipment operation
Leads in root cause analysis; leads and writes laboratory investigations
Reviews equipment calibration and maintenance; instrument advocate and subject matter expert
Evaluates novel technology for laboratory/manufacturing application
Leads lab initiatives or programs and trains analysts on those initiatives/programs. Utilizes change control systems.
Represents the laboratory as the Subject Matter Expert in all major test disciplines and processes
Tracks and reports laboratory performance metrics
Facilitates and leads laboratory investigations; interfaces with QA in the execution of product quality investigations.
Coordinates/supports other departments to ensure smooth execution of work.
Performs all lab functions in compliance with cGMP. The QC AS&T Supervisor must have a mastery of a broad range of techniques in order to support the Analytical Science & Technology team.
Performs troubleshooting of test methods as required. Participates in training technicians and analysts.
Supports and facilitates the continued implementation and maintenance of the lab data integrity program; provides DI training and coaching to team, as required.
Supports the implementation of Laboratory Information Management System (LIMS).
Collaborates with QC Manager to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
Leads improvement areas and develops lab procedures and related processes.
Do You Have…
We are looking for professionals with these required skills to achieve our goals:
Education: BS in AS&T with 8 years’ experience in a AS&T lab, preferably in the pharmaceutical or biotech industry; with 3-5 years of that experience in a leadership role in the AS&T lab. Experience in an aseptic processing cGMP AS&T testing laboratory environment with strong knowledge of regulatory, Health Canada and FDA requirements as related to AS&T testing and laboratory functions.
10 years of professional experience in pharmaceutical lab or manufacturing areas which may include supervisory experience
Technical proficiency and understanding of sterile products manufacturing and testing requirements, lab investigations and data integrity requirements required.
Prior experience qualifying methods and experience with validating methods is required.
Prior experience qualifying analytical instruments is required.
Ability to effectively lead multiple projects, coordinate direct reports and drive results. Continuously drive to improve process for improved performance.
Complexity and problem-solving skills as well as analytical skills with systematic approaches are required to coordinate multiple activities and to drive solutions.
Expert level knowledge of USP, Ph. Eur. Pharmacopoeia.
Advanced to expert level 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) Excellent communication both verbal and written skills concerning testing and sampling scheduling with other departments and external labs/vendors
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.