SRG is a Global Life Sciences staffing and consulting firm and we are seeking a Staff QE-Microbiology with a strong understanding of the ISO regulations for Biocompatibility and have experience with blood contact devices.
Primary responsibilities will be to support, plan, manage, and execute the daily, short-term and long-term activities, and goals associated with biocompatibility requirements. In addition, acts as a consultant for environmental monitoring, sterilization, pyrogen and bioburden testing programs to support the manufacturing of various AAA devices.
- Assure that activities are in compliance with the respective areas that are applicable from FDA GMP/GLP, ISO 10993, 13485, 25539, CMDR, CMDCAS, euMDR, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as applicable.
- Own the design and execution of biocompatibility and chemical characterization studies. Schedules projects to ensure that deadlines are met.
- Anticipate issues and troubleshoot complex technical problems.
- Oversee qualification/verification of analytical test methods and instrumentation including supporting documentation, procedures, protocols and reports.
- Contributes to out of specification (OOS) and/or microbial testing laboratory investigations.
- Provide data review, process trending, and procedural updates and provide technical support for sterilization validation protocol writing as needed.
- Validate, if required, improvements to current methods.
- Schedules projects to ensure that deadlines are met.
- Support internal and external audits as the biocompatibility subject matter expert. Act as the back up SME for microbiology, sterilization, pyrogen, bioburden, and environmental monitoring as needed.
- Support sustaining and new product projects.
- Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
- Communicate effectively to all levels of an organization.
- Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
- Strong verbal, technical writing and interpersonal skills are required. Project Management and prioritization skills. Audit and Investigation Skills, Report Writing Skills.
- Position may require infrequent (~1x/quarter) domestic travel
- Perform other duties as assigned by supervisor
· Experience in biocompatibility testing requirements and contract lab management.
· Familiarity with routine environmental monitoring, sterilization, pyrogen testing and data trending programs.
· Demonstrated knowledge of and ability to apply GxP regulations
· Prior interactions with domestic and international regulatory agencies.
· Ability to effectively work in an interdisciplinary setting.
· BS/BA or MS/MA degree in the biological or chemical sciences with an emphasis on microbiology.
- Eight years with a Bachelor’s degree, Five years with a Master’s degree or a PhD, of directly relevant experience. Class III medical device experience strongly preferred.
- Polymer manufacturing experience preferred
your application has been submitted
Back to job search