We are actively seeking to recruit a Senior QC Specialist experienced in both Bioassays and Immunoassays.
This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, implementing continuous improvement projects and
supporting a lean culture and Right First Time (RFT).
• Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robotsm is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
Qualifications and Experience
• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Experience in Bioassays, Immunoassays and Cell Culture is essential.
• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision.
• Skilled in the use of problem solving tools/techniques