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QC Analyst (NPI)

  • Job reference: 29155
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 14/11/2019

Orion Group Sciences are looking for a QC Analyst (NPI) for our multinational pharmaceutical client based in the South of Dublin on an initial 12-month contract with the potential to extend.

Job Purpose
Plan and Perform non-core chemical analytical high volume NPI testing activities in adherence with agreed testing turnaround time. QC Representative for NPI activities and routine Product meetings

Main Responsibilities of the role

  • Assist with activities related to QC projects and/or QC tasks within Site projects
  • Manage all sample management activities related to NPI activities throughout the site
  • Create/own and approve protocols, sample plans, SOP and documentation related to NPI
  • Responsible for their own training and safety compliance
  • Sample shipments and temperature monitoring activities for NPI activities
  • LIMS data coordination of non-core (NPI) activities
  • Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management
    -Contributes to the completion of milestones associated with specific projects or activities within team
  • With a high degree of technical flexibility, work across diverse areas within QC
  • Plan and perform analyses with great efficiency and accuracy
  • 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
  • May conduct lab investigations as necessary
  • Evaluate lab practices for compliance on a continuous basis / Approve lab results
  • May represent the department/organization on various team
  • Create APPX data files and randomisation memo to facilitate data analysis
  • LIMS data coordination of commercial and import testing on site where applicable
  • May provide technical guidance / May contribute to regulatory filings

Desired Experience and Background of the successful candidate

  • Bachelor's degree in a Science related field is required
  • 5+ years of bio/pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Experience in both Wet Chemistry and HPLC testing techniques
  • Extensive experience in laboratory systems such as sample management LIMS, Velquest / Smartlab, Empower software etc.
  • 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
  • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
  • Escalate issues professionally and on a timely basis
  • Investigation skills / Develops solutions to technical problems of moderate complexity
  • Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
  • Ensures compliance within regulatory environment / Demonstrated ability to interact with regulatory agencies
  • 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
  • Refers to technical standards, principles, theories and precedents as needed
  • 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

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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