An exciting opportunity for a Senior QC Analyst with pharmaceutical industry experience supporting New Product Introductions or working within a fast paced GMP laboratory to join the QC team within an expanding biotechnology company in South Dublin. A strong background in HPLC and the ability to troubleshoot independently is required for this role. Experience working with biologics, protein analysis or API's is desired. Previous exposure to working with New Product Introductions or supporting analysis associated with method transfers is an advantage.
12 month contract with the prospect of extension due to the pipeline of work.
Days role.
Primary 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
- QC Representative responsible for Method Validation and Transfers co-ordination and readiness.
Job Summary:
- Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within team
- This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Qualifications
- Bachelor's degree in a science discipline.
- 3 - 5 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Strong background in Chemistry and Analytical testing is required
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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