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Senior QC Associate

Job in Dublin - Ireland ,

Company: Anonymous
Contract position
Listed on 2019-11-15
Job specializations:
  • Laboratory/Lab Tech
    Laboratory Analysis, Medical Lab Technician, Medical Technologist
  • Biotech
Job Description & How to Apply Below
QC Senior Associate NPI

We are actively seeking to recruit an experienced QC Specialist to become a key member of the quality team within a leading Dublin based pharmaceutical multinational

This successful candidate will support QC and manufacturing operations and be the QC representative for NPI activities. This is an excellent opportunity to advance your career within a fast paced, dynamic environment.


Key Responsibilities,

• QC Representative for NPI activities and routine Product meetings

• Assist with activities related to QC projects and/or QC tasks within Site projects

• Plan and Perform non-core testing related to NPI activities

• 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.


• 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.


Knowledge:

• Bachelor's degree in a Science related field is required.

• 5+ 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 cGMP manufacturing and testing of pharmaceutical products.


• 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

Skills:

• Communication skills (verbal and written) at all levels
Position Requirements
1 to 2 Years work experience
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