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Details

Senior Associate QC


Reference:JSC00029920 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Nurse Associate, QC Analyst


We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties


• With a high degree of technical flexibility, work across diverse areas within the lab

• 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 controlled documents, 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.



Education & Experience


• 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

• 3+ years of industry experience using HPLC.

•Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels, Capillary Electrophoresis, pH, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.

• 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

• Demonstrated leadership and communication skills

• Auditing documentation and operation process

• Demonstrated ability to interact with regulatory agencies
Relevant experience:

• Bachelor’s degree in a science discipline.


• Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.