Global Biopharmaceutical Company in Carlow Offers Contract Opportunity for QC Bioassay Analyst.
About the Project
The company operates a state-of-the-art vaccines and biologics manufacturing facility, producing products in various therapeutic areas including oncology, autoimmunity, pneumonia, and infectious disease.
Key Responsibilities
1. Ensure timely completion of all assigned data processing and reviewing tasks.
2. Complete Laboratory Investigation Reports and deviations through site procedures in a timely manner.
3. Participate in generating trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
4. Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
5. Peer review testing documentation to ensure data integrity compliance and QC Right First Time KPIs are achieved.
6. Review, approve, and trend test results where applicable.
7. Participate in laboratory aspects of OOS investigations.
About You
* Experience: At least 2 years in a cGMP laboratory environment.
* Education: Bachelor's Degree or higher in a science-related discipline is preferred.
* Knowledge: Regulatory/cGMP requirements to Irish, European, and International Codes, Standards, and Practices.
* Lean Six Sigma Methodology understanding is a plus.
* Visa: Applicants must have a Stamp 1 G or a Stamp 4 visa; note that visa sponsorship is not provided.