QC Microbiology (Senior)

Amgen Inc.

3.6

(9)

Dublin, Ireland

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-188254

    Position summary

    and accuracy
    • Demonstrate technical flexibility by working across diverse areas within the lab.
    • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
    • Report, evaluate, back-up/archive, trend and approve analytical data.
    • Troubleshoot, solve problems and communicate with stakeholders.
    • Initiate and/or implement changes in controlled documents.
    • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
    • Write protocols and perform assay validation and assist in equipment qualification/verification.
    • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
    • Approve lab results
    • May participate in lab investigations.
    • May provide technical guidance.
    • May contribute to regulatory filings.
    • May represent the department/organization on various teams.
    • May interact with outside resources.

    Basic Qualifications

    Bachelors degree in a science discipline
    • Biopharmaceutical QC experience in a microbiology lab
    • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

    Preferred Experience/Knowledge
    • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden (In-process product & Utility samples), Endotoxin (Kinetic and Gel clot), Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Growth Promotion, Media prep, Water Sampling.
    • Understanding and application of principles, concepts, theories and standards of GMP QC Microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
    • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

    Skills
    • Take initiative to identify and drive improvements
    • Excellent verbal and written communication skills
    • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
    • Presentation skills
    • Escalate issues professionally and on a timely basis
    • Decision Making skills
    • Teamwork and Coaching others
    • Negotiation and Influence skills
    • Problem solving skills
    • Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
    • Ensures compliance within regulatory environment
    • Develops solutions to technical problems of moderate complexity
    • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
    • Interprets generally defined practices and methods
    • Able to use statistical analysis tools to perform data trending and evaluation
    • Project Management and organizational skills, including ability to follow assignments through to completion

    Competencies:

    • Background in microbiology and aseptic manufacturing

    • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage

    • Flexibility - the role often encounters changing priorities (also required to work weekend on call - Rota system)

    • Follows procedures and ALCOA principles

    • Demonstrated ability to work independently and deliver right first time results

    • Works under minimal direction, recognizes and escalates problems

    • Work is guided by objectives of the department or assignment

    • Refers to technical standards, principles, theories and precedents as needed

    • May set project timeframes and priorities based on project objectives and ongoing assignments.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging