7611 Northland Drive North Crystal, MN 55428 US
HM's Top 3:
- written and verbal communication skills
- experience with industrial sterilization and the application of applicable standards (ISO 11135, ISO 11737-1 and -2, ST72
- Ability to effectively communicate technical information to individuals from different functional groups
Education Required: Bachelors degree in a science field (microbiology, biology, chemistry, physics, engineering)
Years’ Experience Required: >1year
Does this position require the candidate to be onsite or remote? Local would be beneficial, but open to remote
Responsibilities may include the following and other duties may be assigned. Analyzes biological or microbiological products raw materials inprocess materials release test samples or stability samples in support of the company's quality program.Provide support to remediate existing product documentation to ensure compliance with EU MDR requirements. Write and execute protocols to close any compliance gaps identified. Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary. Develops validates and implements controlled environment methods. Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency or devises and develops new analytical methods and techniques. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. May also be involved in establishing requirements for the transfer of methodology from R&D.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information status needs and issues in order to inform gain input and support decision making.
Nice to have: prior experience with the application of international standards including ISO 11135 ISO 11737-1 ANSI/AAMI ST72.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.