Ireland Job Openings

Mallinckrodt

QC Analyst

Dublin

FULL TIME

August 12, 2024

Job Title
QC Analyst
Requisition
JR000014340 QC Analyst (Open)
Location
Dublin, IRL
Additional Locations
Job Description Summary
Job Description
SUMMARY OF POSITION:
This position as part of a start-up provides an excellent opportunity for the appropriate candidate to make their mark within the QC function of a niche product in a new manufacturing facility. The role of QC Analyst will aide in the setup of a new QC laboratory and will be responsible for the analytical testing. The analyst will get exposure to wide variety of analytical techniques and will also get the opportunity to work with the process development function located onsite.
BACKGROUND AND CONTEXT:
The Global External Supply (GES) organization was created as part of Mallinckrodt’s corporate aspiration to become a top quartile specialty biopharmaceutical company within the next 5 years. This has resulted in expenditure of more than $7 bn on a series of acquisitions (Questcor, Ikaria, Therakos) to date, with further BD&L (Business Development & Licensing) activity anticipated.
GES is located in Dublin, Ireland.
ESSENTIAL FUNCTIONS:
The main areas of responsibility of this role are as follows:
  • Aide in the setup of a new QC laboratory
  • Input into the purchase and installation of new equipment - oversee IQ/OQ where applicable
  • Draft and review documentation – SOPs, protocols, training modules, investigations, reports and Trackwise documents
  • Actively participate in analytical method transfers and method validations as required
  • Conduct and document out-of-specification/out-of-trend result investigations
  • Responsible for the day to day running of the QC laboratory
  • Experience with wet chemistry, GC, HPLC, Electrophoresis, ELISA and a willingness to learn new analytical techniques as the laboratory evolves
  • Work within the test schedule for the facility and the stability programmes
  • Day to day activities required for running of the laboratory
MINIMUM REQUIREMENTS:
Education:
  • Minimum BSc in Science
  • Advanced degree preferred
Experience:
  • Minimum 2 years’ experience in a similar role
  • Must include role(s) within a QC setting
  • Solid experience of GC required ELISA, cell based experience desirable
  • Experience with method validation/ method development
  • Sterile manufacturing and/or biotech experience is preferable
  • Pharmaceutical drug/process development experience preferable
Skills/Competencies:
  • Self-starter with strong work ethic
  • Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • Must be able to function effectively in a teamwork environment
  • Ability to identify, execute and prioritize work tasks/projects and know when to escalate
  • Excellent problem-solving, decision-making and communication skills
  • Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Power Point, SAP, Track Wise, Empower, SAP)
  • Ability to plan, organize, and prioritize effectively
  • Good technical and compliance-based writing skills
  • High levels of integrity and trustworthiness
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