- Ensure that the activities of the stability program are in compliance with effective Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
- Work to streamline and continuously improve stability operations including, but not limited to, expanding the stability program capabilities to include more storage conditions, to utilize the full storage capacities of existing chambers, and to create/revise spreadsheets and processes for efficiency and cGMP compliance.
- Work closely with Program Managers, Clients, and QC analysts to ensure the timely execution of stability protocols, staging, time point pulls, in-house or external testing, and summary reports.
- Write, revise, and review SOPs and GMP documentation as needed, such as stability study protocols, amendments, and summary reports.
- Ensure that stability samples for all projects are properly placed on stability on time at the correct storage conditions and accurate logs are filled out for traceability.
- Follow the requirements of each stability protocol to maintain all required timelines, including ensuring that stability samples are pulled accurately at each time point, tested, and reported to Clients within the designated time frames.
- Coordinate and oversee stability testing, both in-house and external. Coordinate and manage external testing labs to include shipping samples, tracking progress, and managing timelines. Obtain quotes and process Purchase Requisitions. Review testing results and COAs.
- Ensure stability chambers are maintained in a calibrated / qualified state and meet ICH guidelines.
- Attend planned meetings as needed to prioritize the stability program.
- Recognize potential trends and alert the QC Director about potential issues.
- Interface with investigators during internal and external inspections/audits.
- Report excursions/out of specifications results and conduct investigations as needed.
- Assure the implementation of appropriate and timely corrective actions.
- Identify deviations and report possible preventative and corrective actions using Trackwise.
- Perform other duties as assigned.
Required Skills & Abilities:
- Sound understanding of analytical instrumentation and methodologies. For example, chromatography and spectrophotometry, wet chemistry.
- Operate as a team leader, coordinate staff scheduling and training.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Ability to multi-task and prioritize work assignments with little supervision.
- Excellent attention to detail.
- Computer proficiency required.
- Ability to accurately review and complete required documentation.
- Excellent written and oral communication skills.
- Excellent organization and analytical skills.
- Ability to manage multiple simultaneous projects.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- Bachelors or Master’s degree in Chemistry, Biochemistry, or an applicable scientific discipline with at least five (5) years’ industry experience in a GMP /GxP or a comparable federally regulated environment.
- Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
- Sound understanding of ICH guidelines for stability testing.
- Experience in Trackwise Deviation Management software.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.