QC Associate (Senior)
- Dublin
- Contract
- Full-time
The successful candidates responsible for one or more of the following activities in QC include analytical testing of EU release, commercial, stability, utilities, raw materials and validation.The Job:
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure & continuous learning.
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
- 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.
- Bachelor's degree in a Science related field is required.
- 4+ 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.
- Demonstrated ability to work independently and deliver right first-time results.
- Works under minimal directions are guided by objectives of the department or assignment.
- Refers to technical standards, principles, theories and precedents as needed.
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems.
- Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.