A QC Support Coordinator is required for a Limerick based client on an initial 12-month contract basis. The QC Support Coordinator will co-ordinate sample flow through QC internal laboratories and external contract laboratories. You will be the single point of contact between our client and external contract laboratories to oversee testing. You will also set up and approve contract laboratories for testing and support QC requirements by performing data monitoring and trending. This is a desk-based role and our client is very open to consider candidates coming from either a lab or desk based role.
- Set up (approve) contract laboratories using Quality Agreements and Master Service Agreements.
- Work with the contract laboratories to ensure samples are delivered to them on time and testing is completed as per the requirements.
- Plan, prioritize and co-ordinate sample management and method transfer activities to the external contract laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
- Use a sample tracking system (LIMS) to maintain sample chain of custody, review sample status and test result status.
- Review, analyze and trend data results from internal and external contract labs and monitor for any Out-of-Trend (OOT) excursions.
- Create and review QC Certificate of Analysis and lot release reports.
- Compare data from external contract labs to internal data trending programs.
- Report results to management on a timely basis.
- Document and communicate discrepancies to appropriate personnel in a timely and efficient manner.
- Assist the external contract laboratories in troubleshooting and identifying root cause analysis and provide technical advice as needed.
- Perform quality system activities; Complete CAPAs and Change Controls, Initiate and revise SOPs as required.
- A third level qualification (BSc degree or higher) in biology, chemistry, microbiology or related field.
- 2+ years hands-on work experience working in laboratory to cGMP regulatory guidelines or c2 years' experience working in a GMP environment experience.
- Excellent Communication skills, both verbal & written.
- Experience with electronic systems such as LIMS, Empower, JMP, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage but not essential for this role.
- Strong analytical ability and associated problem solving.
- Good time management and attention to detail.
- Knowledge and proficient in the use of Microsoft products including, Project, Excel, Word and PowerPoint.
This is an excellent opportunity to join a great team of c6 people within a large company. This role is with a leading company that is consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies.
Please contact Michelle Galvin on (091 373 938) firstname.lastname@example.org for further information on this exciting new opportunity.
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