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Senior QC Associate (HPLC)

  • Job reference: 927166
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 19/08/2019

Hello all. I am currently seeking a Senior QC Associate (HPLC) for an initial 12-month contract with our client in the South of Dublin. Please contact me at Andreia.Terron@orioneng.com for more details

Senior QC Associate (HPLC)

Description: Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, 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 manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Primarily responsible for Senior QC Associate (HPLC) activities, which may include any/all of the following:

  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform routine analyses with 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
  • 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
  • Approve lab results
  • May participate in lab investigations
  • May provide technical guidance
  • May train others
  • May contribute to regulatory filings
  • May represent the department/organization on various teams
  • May interact with outside resources

Basic Qualifications:

  • Bachelor's degree in a science discipline.
  • 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
  • At least 3 years HPLC experience in QC GMP Lab
  • Knowledge:
    Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels or
    Capillary Electrophoresis.
    * 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)
  • 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
  • Demonstrated ability to work independently and deliver right first time results
  • 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
  • Demonstrated leadership and communication skills
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies

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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