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QC In Process Analyst - Contract

Job Title: QC In Process Analyst - Contract
Contract Type: Contract
Location: Cork
REF: 98257
Job Published: 2 months ago

Job Description

All applicants must have a working visa for Ireland for this contract role

Contact: Niamh Hlubek
Telephone: 086 8168298

QC In Process Analyst - Contract

Our client, a medical device company in Cork are currently looking to recruit QC Analyst for their site on a contract basis.

  • This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good
  • Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

Key point to note:
  • 4-cycle shift (initially person may be on days for a no. of weeks to allow for training to be completed)
  • Key analytical technique required: HPLC
  • Other desirable techniques: A280 and Nephelometry testing, residual protein assay, TOC analysis

General Responsibilities
  • Achieves competency in laboratory methods and procedures.
  • Trains other QC analysts in laboratory methods and procedures when required.
  • Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
  • Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
  • Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
  • Performs routine and non-routine analytical testing activities.
  • Review and approval (where appropriate) of laboratory test results.
  • Ensures that testing and results approval are completed within agreed turnaround times.
  • Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
  • Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
  • Deals with non-conformances/ deviations in an accurate and timely manner.
  • Deputizes for the QC Team Leader as appropriate.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.
  • In process control testing and activities to support the production units.

Qualifications and experience
  • A third level qualification of a scientific/technical discipline is required.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  • Builds strong productive relationships.
  • Demonstrates ability to work with teams and individuals
  • Asserts personal ideas and opinions using persuasion to influence others
  • Seeks opportunities to grow and develop professionally
  • Uses best practices to improve business operations
  • Holds self-accountable for compliant and flawless execution
  • Takes personal responsibility for decisions that successfully build customer value
  • Effectively manages and adapts to change
  • Demonstrates the courage to stand alone on ideas and opinions that differ from others
  • Listens effectively and remains open to other’s ideas.
  • Works effectively with people that have diverse styles, talents and ideas
  • Maintains the highest standards of ethical behaviour
  • Treats people with dignity and respect

Significant Environmental, Health and Safety Considerations
  • All employees are required to comply with the requirements of the company’s Environmental Health and Safety Policy, Safety
  • Statement, associated EHS Procedures and local legislation.
  • Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
  • Comply with EHS rules and procedures always.
  • Understand the potential EHS impact of their activities
  • Attend and participate in EHS training as required
  • Use PPE and safety equipment as required.
  • Report all incidents, accidents, and near miss events.
  • Report unsafe plant, equipment, acts, procedures or issues
  • Make suggestions to improve health and safety in the workplace.
  • Actively participate in work area EHS teams.
  • Not turn a ‘blind eye’ to unsafe acts or situations

For further information on this QC Analyst role in Cork please contact Niamh Hlubek 086 8168298 /

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