Job Type: Contract
Job ID: JO-1908-19262
Consultant: Karen McHugh
Are you a QC analyst with 4+ years experience testing Bioassays, Immunoassays and Cell Culture within a biotech environment?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Senior QC Analyst - Bioassays - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues.
The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT).
The role also represents the QC unit by liaising with internal and external customers.
Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots 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.
Lead training of staff on technical aspects of job as required.
Develop, revise and implement procedures that comply with appropriate regulatory requirements.
Qualification of analytical equipment and related testing functions.
Participate in Analytical Method Transfers
Compliance with Standard Operating Procedures and Registered specifications.
Ensure the laboratory is operated in a safe manner
Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
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.
Participate in regulatory agency inspections as required.
Plan and implement procedures and systems to maximise operating efficiency.
Manage and contribute to the achievements of department productivity and quality goals.
Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
Have 4+ years of experience in a pharmaceutical/healthcare Laboratory.
Experience in Bioassays, Immunoassays and Cell Culture is essential.
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
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
Excellent Hourly Rate
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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