Our client, one of the largest Contract Research Organizations in Athlone is recruiting for QC Supervisor role . The successful candidate will Assures the quality of laboratory data and reports through supervision of analytical review staff and performance of Quality Control (QC) reviews. Monitors consistency in interpretation of procedural requirements and the content of QC reports. Resolves inconsistencies between the laboratory and QC and assure compliance with FDA Good Laboratory Practices and /or Good Manufacturing Practice
· Consults with laboratory management regarding priority of data and reports submit-ted to QC and assigns work accordingly. Supervises QC staff to include scheduling, procedural interpretation and performance evaluation.
· Trains new QC Reviewers and laboratory staff.
· Evaluates lab data for compliance with methods, SOPs, quality and project timelines. Serves as primary contact for the laboratory unit regarding compliance issues.
· Consults with QC staff and laboratory staff to mediate disagreements that may arise. Monitors consistency in interpretation of procedural requirements and content of QC reports.
· Evaluates findings produced by QC staff and determines appropriate action.
· Identifies issues that may require follow-up inspection. Reports findings to laboratory staff and management.
· Participates in client and regulatory inspections providing information regarding the QC program. Facilitates responses from the lab and retrieval of data.
· Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training, & experience.
· 5+ years Quality Control or Quality Assurance experience with 1+ year of leadership responsibility
· Knowledge of SOPs and Federal Regulations to include GLP and GMP
· Knowledge of analytical methodologies, instrumentation and method validation
· Thorough knowledge of chromatography and divisional SOPs
· Strong verbal and written communication skills
· Strong attention to detail
· Ability to deal with multiple and changing priorities
· Leadership and time management skills
· Ability to train and mentor staff
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255