We are actively seeking to recruit a Senior QC Specialist to become an integral part of the quality team within a leading biopharmaceutical multinational
The successful candidate will be responsible for and gain exposure to, HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance.
This role will support manufacturing operations, as such work will be as part of a 24/7 shift pattern and flexibility may be necessary.
• Plan and perform routine analyses with efficiency and accuracy.
• 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.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Approve lab results.
• Bachelor’s degree in a science discipline.
• 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 GMP manufacturing and testing of pharmaceutical products.
• Experience in a wide variety of analytical techniques including but not limited to HPLC, Capillary Electrophoresis, UV, FTIR, suv -vis particle testing