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Lead QC Analyst - Shift

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 09/10/2018
  • Job reference: BBBH90065

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Lead QC Analyst


A Lead QC Analyst (shift) is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for performing a variety of chemical analyses on raw materials, final products, in-process materials, or stability samples in support of the company's quality program. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.

Responsibilities

  • Gathers data and documents test results.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Complies with all pertinent regulatory agency requirements.
  • Participates in required training activities.
  • Maintains laboratory supplies.
  • Conducts testing on raw materials, in-process, product, stability, and/or research samples.
  • Writes and revises control test procedures and SOPs.
  • Completes test records and reviews data.
  • Calibrates or verifies calibration of instruments/devices prior to use.
  • Interacts with outside customers or functional peer groups.
  • May be responsible for maintaining a specific project.
  • May devise or develop new analytical methods and techniques.
  • May assist in validation of methods.
  • May be involved in establishing the transfer of methodology from R&D.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedure
  • Maybe required to review and approve Laboratory Investigations
  • Act as area SME for Internal and External Inspections



Lead-Related Activities include, but are not limited to;

  • Provides on-the-floor guidance and support to employees.
  • Ensures employees timesheets are completed on time.
  • Monitors employees training to ensure that all requirements are met, including OJT.
  • Maintain up to date training records for self and direct reports.
  • Perform minimally monthly performance feedback meetings with direct reports.
  • Represent area management at leadership meetings as required
  • Escalates all performance issues to management and/or HR.



Education/Experience

  • A third level qualification (BSc degree or higher) in chemistry, biology or related field. Preferably with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry

  • Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
  • Adaptable and flexible, willing to work shift if required and willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint.



Preferred Laboratory Experience in one or more of the following areas;

  • Analytical
    • HPLC
    • UPLC
    • UV-Vis spectrophotometry
    • Densitometry
    • Wet chemistry testing techniques including pH, conductivity, appearance and osmolality
  • Raw Material
    • FTIR, NIR spectroscopy
    • Familiar with USP, JP and EP methodology

Interested?

Call Jack on 01-6455250, or email jack.conway-kenny AT experis.ie for more info!

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