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QC Microbiology Associate

  • Job reference: 929005
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 05/12/2019

Orion Group Sciences are looking for a QC Microbiology Associate for our multinational pharmaceutical client based in the South of Dublin on an initial 6-month contract with the potential to extend.

Job Purpose
Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers and verification, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team.

Main Responsibilities of the role

  • Environmental Monitoring of Grade 8/9 Cleanrooms
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
  • Reading of Environmental Monitoring Plates
  • Bioburden testing of water & disinfectants
  • Writing technical reports
  • Water sampling
  • Testing of In Process samples such as Protein Concentration, Density & pH
  • Perform analytical testing as a main priority with efficiency and accuracy
  • With a high degree of technical flexibility, work 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 equipment qualification/verification
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis

Desired Experience and Background of the successful candidate

  • Bachelor's degree in a science discipline
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Experience working in an aseptic cleanroom performing Environmental Monitoring
  • Proficient in the use of LIMS & LMES
  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, 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
  • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
  • Flexibility - the EM role often encounters changing priorities on a daily basis (also required to work every 3rd weekend on call)
  • Experience with Regulatory inspectors and interacting with inspector's desirable
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies
  • Must have EM experience - ideally GMP lab - ideally 3 years

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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