Job Details

  • Title: Biocompatibility Specialist
  • Code: RCI-3095165
  • Location: West Chester Pennsylvania (PA) 19380
  • Posted Date: 09/28/2020
  • Duration: 4-6 Months
Talk to our Recruiter

  Job Description

  • Coordinate test samples for evaluation at internal and external contract laboratories, including calculation of sample numbers required for testing, ensuring proper labelling of samples, and clear communication with research teams providing samples
  • Requesting quotes from CROs, place and maintain purchase orders within the purchasing systems
  • Receiving and distributing samples as per GLP and departmental SOPs, maintaining accurate and contemporary tracking records
  • Track study progress to ensure timely delivery of data and reports
  • Ensure appropriate documentation is established & maintained in study files to ensure study integrity and timely submission to document archives; verify information in protocols and reports
  • Act independently as sponsor’s representative for compendial studies
  • Ensure that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices and Radiological Health) and GLP (Good Laboratory Practice)
  • Support the team in maintaining the LCM request tool (ticketing system) for the tracking of requests and recording of department activities
  • Maintain team project tracker to allow for preparation of metrics and reporting to management
  • Support the team and report to management on department activities, non-conformances, and problems related to sample preparation, CRO delays, and overall project flow for planning purposes (Update of project Dashboard)
  • Maintain a collaborative spirit of the work environment that is both professional and ensures the engagement of others as partners and team members.
  • Communication with the labs regarding testing times, prioritization of test items if required, communication with other franchises regarding testing priorities
  • Update of document Pointers in PLM System Agile to represent documents stored in PLM System Windchill

Education & Experience Requirements:

  • A Bachelor’s degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field or similar educations with work experience in the medical devices/pharmaceutical industry is required
  • A minimum of 2 years of experience in industrial research, academic research, or product development experience in a highly regulated healthcare environment is required
  • Experience working with contract research organizations is preferred
  • Ability to work collaboratively as a team member across various functions in a challenging and changing environment is required
  • Experience working in a regulated environment of medical device safety and supporting product submission and audit to support worldwide market registration is preferred
  • Proven experience with project management skills, managing priorities and time management is required
  • Ability to be on-site to execute sample transfers in a timely manner is required
  • Familiarity with medical device product development is preferred
  • Excellent communication skills to serve as a Toxicology and Biocompatibility spokesperson on scheduling issues (as appropriate) is required
  • Ability to handle multiple tasks and responsibilities and prioritize tasks according to broad project goals is required