QC Bioassay Analyst
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a QC Bioassay analyst to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic Drug Substance facility.
- Qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods.
- Key in the layout of the lab testing to ensure the process is streamlined and in line with lean methodologies.
- Key talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to.
- The candidate will support the complete analytical lab build.
- The candidate will work with a high performing cross functional team of talent sourced from across the biotechnology industry.
- The full analytical scope will incorporate micro, chemistry, mycoplasma, bioassay, raw materials, stability and in-process.
- Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future.
- The candidate will participate in analytical transfer and qualification of methods.
- Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
- Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
- Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Writing and update of SOPs.
- Maintain good housekeeping and hygiene within the laboratory.
- Cleaning and routine equipment maintenance.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Delivery of area performance to meet or exceed performance or quality goals.
- Promote and participate the implementation and maintenance of the relevant safety programmes.
- Participate and comply with the Quality Management System requirements.
- Drive a culture of Continuous Improvement by deploying Six Sigma tools.
- Assist in the “operationalising” of the lab with a strong focus on MPS.
- Ensure training is current for all job functions performed.
- Assist in training new QC Analysts on routine procedures and practices.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Focus on delivering value for customers, including patients, by understanding and meeting their needs.
- Actively listen and seek to understand of all activities assigned and ensure all improvements and streamlining of such activities is taken into consideration.
- Speak openly, honestly and with conviction; have the courage to take appropriate risks while ensure laboratory GMP activities are always adhered too.
- Make timely decisions at the right level with the right data, document decisions and support them once made.
- Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results, while supporting others.
- Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
- Build diverse talent with the capabilities necessary to succeed in commercial biologic manufacture; inspire, reward and develop to ensure you and those working within you reach their potential.
Qualifications, Skills & Experience Required
- 3 years minimum industry experience with significant knowledge and experience working in a QC laboratory testing environment within the biological and/or pharmaceutical industry.
- Experience in Potency, Residual protein A and HCP Elisa method.
- Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
- Good working knowledge of QC Systems (SoftMax Pro, Gen5, EN, LIMS) and Trackwise
- Degree qualification (Science/Quality/Technical).
- Preference Lean Six Sigm
- Strong knowledge and experience of Bioassay methods.
- Ability to respond to changing priorities
- Strong organisational skills
- Good verbal and written communication skills
- Excellent troubleshooting and problem-solving skills
- Good attention to detail
- Ability to think logically and be proactive.
- Ability to work as part of a team and on own initiative in a constructive manner
- Flexible and self-motivated
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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