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Sr Associate Quality Control - Ireland  

Amgen (company)


Posted on : 01 May 2017

Project Description

Job Summary:
  • Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
  • Contributes to team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within team
  • This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Specific Job Duties:
  • Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL)  regarding all stability programme matters.
  • Perform routine sample management tasks as per procedures.
  • With a high degree of technical flexibility, work across diverse areas within QC
  • Plan and perform routine tasks with efficiency and accuracy.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.
  • Report, evaluate, back-up/archive, trend and approve 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 validation and equipment qualification/ verification. Operate and maintain specialised equipment.
  • Introduce new techniques/ Processes  to the area, where appropriate.
  • Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
  • LIMS data  coordination of  commercial and import testing on site where applicable
  • May provide technical guidance.May contribute to regulatory filings.
  • May represent the department/organization on various teams. May train others.
  • May interact with outside resources.
  • Perform general housekeeping in all sample management areas.
  • Primary knowledge, skills, competencies and relevant experience

  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.  
  • Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

  • Take initiative to identify and drive improvements
  • Communication skills (verbal and written) at all levelsStrong 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
  • Investigation skills
  • Problem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures 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

  • Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction Work is guided by objectives of the department or assignment
  • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments
  • Recognizes and escalates problems
  • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies

Relevant experience: 
  • Bachelor’s degree in a Science related field is required. 
  • 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with a minimum of 2 – 3 years of specific sample management/ stability programme management experience. 
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.