QC Bioanalytical Chemist

  • Job Reference: 472870653-2
  • Date Posted: 14 January 2022
  • Recruiter: Confidential
  • Location: Dublin, County Dublin
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Contract

Job Description

Role Summary

* The QC Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for verifying the raw materials analytical methods and performing supplier qualification.

* The successful candidate will be key in the layout of the lab testing to ensure the process is streamlined and in line with site lean methodologies. He/She will be the key talent in analytical raw materials techniques and in Pharmacopeia methods.

* The facility will utilize the latest innovations in technology and automation and latest in analytical technics. The candidate will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Together, the team will build the future of the biologics facility through a Quality culture that delivers unconstrained supply, Right First Time to patients through an inspired team.

* The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.

* The full analytical scope will incorporate micro, chemistry, 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 have responsibilities in analytical transfer and qualification of methods.

Core Duties and Responsibilities:

* Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.

* Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration and Appearance in compliance with GMP requirements.

* Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.

* Support the laboratory testing schedule to achieve an efficient QC system.

* Receive and manage samples that come into the lab for stability, in-process and release testing; Solution preparation, cleaning, routine equipment maintenance and system set-up.

* Writing and update of SOPs; Maintain good housekeeping and hygiene within the laboratory.

* Calibrate and maintain all designated laboratory instruments.

* Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.

* 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.

* 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 site Quality Management System requirements; Responsible for driving a culture of Continuous Improvement by deploying site Six Sigma tools.

* This position will be on days with the possibility of shift work when required.

Minimum Qualifications and Experience:

* Degree qualification (Science/Quality/Technical); Master preferred

* Preference Lean Six Sigma

* 1-3 years industry experience with significant knowledge and experience in working in a Raw material lab unit and working with contract labs

* Experienced in testing as per the pharmacopeia

* Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS)

* Ability to respond to changing priorities and strong organisational skills

* Good verbal and written communication skills

* Excellent troubleshooting and problem-solving skills

* Good attention to detail and ability to think logically and be proactive.

* Ability to work as part of a team and on own initiative in a constructive manner

To Apply

If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

14 Danville Business Park, Kilkenny, Ireland
(phone number removed)

Please note, we do not require agency assistance with this role