Arroyo, Puerto Rico, US
Apr 28, 2021
May 06, 2021
Employment Type
Full time
Salary Type
About Stryker
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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 Stryker's 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 what's 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.
, 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
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program. (https://careers.stryker.com/referrals/)