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Sr. Technical Reviewer

Company: Cepheid
Location: Lodi
Posted on: November 18, 2021

Job Description:

POSITION SUMMARY:Responsible for supporting the Bulk Buffer, Reagents and Bead production laboratories by following good documentation practices (cGDP) and relevant standard operating procedures (SOPs). Complete assigned tasks and ensure all activities are compliant with the company s quality, safety and departmental policies and standards. Apply analytical skills or scientific methods or operational processes to perform release testing utilizing the GeneXpert system with moderate guidance and directionESSENTIAL JOB RESPONSIBILITIES:

  • Work safely with hazardous chemicals and follow all safety policies fostering a safe work environment
  • Immediately report all safety concerns including injuries and safety suggestions
  • Uses existing procedures to solve routine or standard problems
  • Responsible for: liquid bead formulation, bulk buffer formulation, bead dropping using a beadulator, loading and unloading beads from the lyophilizer, sieving of beads, aliquoting and labeling of dyes and grease
  • Performs release testing including LSP, PCR, pH, Moisture, Conductivity and Density testing
  • Explains complex information to others in straightforward situations
  • Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents
  • Perform accurate real time documentation to ensure right first time (RFT) operations
  • Perform verification and review of peer activities
  • Train others on testing responsibilities
  • Monitor equipment and inform leads or management of any issues
  • Maintain laboratory housekeeping including reagent and equipment inventory levels
  • Recognize issues and defects and complete necessary documentation and escalate accordingly
  • Recommend and implement improvement ideas in the lab that will positively affect production efficiency, Quality and Safety
  • Assist other department in qualification of new methods and instruments
  • Trouble shoot equipment and assay failures
  • Suggest and assist in SOP revisions
  • Assists management with audit activitiesTRAINING RESPONSIBILITIES:
    • Complete all assigned and required training satisfactorily and on timeMINIMUM REQUIREMENTS:Education and Experience:
      • Bachelor s degree with 2+ years of related work experience OR
      • Master s degree in field with 0-2 years of related work experience.Knowledge and skills:
        • Must be able to follow cGMP and cGLPs, FDA and ISO standards
        • Must be able to follow direction, able to understand SOPs and demonstrate understanding through speech and/or written form
        • Proficiency in computer systems such as Word, Excel, SAP and e-mail
        • Has a good understanding of how the team integrates with others to achieve objectives
        • Requires conceptual knowledge of theories, practices and procedures within a discipline
        • Experience with the GeneXpert systemPhysical requirements/abilities:
          • Must be able to lift 25 Lb Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
          • Ability to transport heavy materials up to 400 Lb with the appropriate machine or equipment assist
          • Ability to work in a controlled environmentPREFERRED REQUIREMENTS:
            • Bachelor s in Life Sciences
            • Experience working in a GMP/ISO manufacturing environment
            • Experience using analytical scales, Pipettes and working with hazardous chemicals
            • Flexibility with the work schedule including modified shift times, overtime and weekendsWhen you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID 19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you ve ever wondered what s within you, there s no better time to find out. Associated topics: clinical, environment, fault, hospital, inspector, risk, safety, waste, water, wwtp

Keywords: Cepheid, Lodi , Sr. Technical Reviewer, IT / Software / Systems , Lodi, California

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