Job Type: Contract
Job ID: JO-1901-12519
Consultant: Karen McHugh
Are you a QC analyst with 4+ years experience within a pharma or biotech environment?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Senior QC Analyst - Incoming Quality - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
The Sr. Associate in Quality Assurance (QA) will be an active member of the ADL QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.
The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr.
Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Incoming Quality Assurance Sr. Associate Key Responsibilities
Testing of primary and secondary components for use in the manufacture of aseptic products.
Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Participates in customer complaint investigations with suppliers of components.
Provide training and advice to staff in relation to testing of components and packaging.
Actively participate in audits and their preparation.
Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
Perform all activities in compliance with Amgen safety standards and SOPs
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager’s request.
University degree. Engineering or Science related discipline preferred.
Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making
Strong organizational skills, including ability to follow assignments through to completion
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Contract rate of €25 - €35 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail firstname.lastname@example.org or call +353-1-7978720
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