Job Description

Who we want:

Challengers. People who seek out hard projects and work to find just the right solutions. Teammates . Partners who listen to ideas, share thoughts and work together to move the business forward. Charismatic networkers . Relationship-savvy people who intentionally make connections with both internal partners and external contacts. Customer-oriented achievers. Representatives with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships. Game changers. Persistent people who will stop at nothing to live out Strykers mission to make healthcare better.

* Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.
* Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
* Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
* Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for whats next.

What will you do:

* Conducting microbiological testing using qualified laboratory equipment and procedures applicable to the department.
* Reviewing and approving microbiological testing data ensuring compliance to the applicable methods and regulatory standard requirements.
* Continuously fully comply with all quality and regulatory standard requirements.
* Conduct microbiological testing such as: Bioburden, Microorganism Identification, Media Preparation, Growth Promotion, Endotoxin, and Sterility Testing using qualified laboratory equipment and following the applicable written procedures.
* Conduct environmental sampling to the manufacturing controlled areas supporting the ECA (Environmental Controlled Area) Monitoring Program.
* Prepare reports related to microbiological analysis, ECA Monitoring Program, and monthly metrics.
* Review and approve data related to the microbiological testing ensuring compliance to requirements set forth in applicable standards and test methods.
* Train new personnel and existing on ECA controls and ensure that the applicable requirements are.
* Train new personnel and existing on microbiology testing and proper testing techniques.
* Assure the laboratory equipment is qualified, calibrated and within PM (Preventive Maintenance) program.
* Conduct analytical method qualification and laboratory equipment validations.
* Provide support during audits (FDA, TUV or other related).
* Review and approve reports of Biological Indicators or sterility analysis (EtO).
* Provide support to the sterilization processes validation.
* Review of Biocompatibility documents.
* Coordinate and manage the testing conducted by external laboratories according to procedures.
* May be required to perform other duties as required to the operations and according to his/her abilities and skills.
* Comply with Health and Occupational Safety politics (EHS).
* May coordinate the work of other associates to ensure timely attainment of results.
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, What you need

* Strong analytical skills
* Strong laboratory aseptic techniques
* Effective interpersonal skills
* Basic PC skills
* Math skills
* Microbiology and sterility testing execution skills
* Intermediate English Level is required
* At least 2 years of experience as an exempt microbiology analyst with at least endotoxin and bioburden method validation experience preferable in medical devices.
* Knowledge in identification of microorganisms.
* Knowledge in microbiology lab equipment installation and operational qualification validations.
* B.S. in Microbiology or Biology, or related discipline from accredited university

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