I have an exciting contract opportunity for an experienced QC Analyst (Chemistry) whoe is looking to utilise there skills and experience to date and join a busy new product introduction team within a leading biopharmaceutical company in Dublin. This is a senior position that requires high volume routine testing, in-depth troubleshooting experience and the ability to work on your own initiative.
Job Summary:
- Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within team
Specific Job Duties:
- With a high degree of technical flexibility, work across diverse areas within QC
- 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.
- May train others as necessary
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/ verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- May conduct lab investigations as necessary
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results
- May represent the department/organization on various teams
- May interact with outside resources.
- Create APPX data files and randomisation memo to facilitate data analysis.
- LIMS data coordination of commercial and import testing on site where applicable
- May provide technical guidance.
- May represent the department/organization on various teams.
Qualifications
- Bachelor's degree in a science discipline.
- 2-4 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Strong background in Chemistry and Analytical testing is required.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Knowledge:
- Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.
- Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
