Assay QC Specialist, Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid Onsite requirement is 3 days per week
Pay: €25 - €33 per hour
Experience: 3+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Plan and perform analyses with great 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.
Review protocols and perform assay validation and equipment qualification/ verifications when required.
Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
May contribute to regulatory filings.
May conduct lab investigations as necessary.
Evaluate lab practices for compliance on a continuous basis.
Approve lab results.
May interact with outside resources.
LIMS data coordination of commercial and import testing on site where applicable
May represent the department/organization on various teams. May train others.
Requirements
Bachelor's degree in a Science related field is required.
3+ 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 cGMP manufacturing and testing of pharmaceutical products.
Be very proficient in the use of Microsoft Word, Excel etc.
Have strong communication and technical writing skills.
Investigation skills
Be detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
Be a self-starter and capable of working on own initiative.
Strong teamwork skills.
Proven track record of meeting deadlines.
Experience with analytical techniques such as Compendial testing would also be advantageous
Package
Contract role - Hourly rate €25 - €33 per hour
Minimum 12 month contract
Onsite Requirements: You'll be expected to work onsite 5 days a week, though occasionally remote work is possible for those document-heavy days.