QC Biochemist - North Wicklow
QC Biochemist - North Wicklow. This position is being offered as an 18 months; fixed-term contract. Purpose of job: To complete routine QC analysis and value assignment to assess suitability of products in the field. All duties to be performed in an ISO and FDA regulated environment where knowledge and adherence to Standard Operating Procedures within the Quality System is required. Essential responsibilities. • Assess suitability of product to the market place by testing product under instructions of the Quality Test Method in the expected time frame allocated as per Master Production Schedule. • Assign lot specific values to applicable calibrator and control plasmas. • Carry out microbiological analysis on material and purified water system. • Generation and completion of Long Term Stability (LTS) protocols for the duration of product shelf life. • To problem solve and complete root cause analysis as required in addition to Out of Specification (OOS) and Quality Event investigation requirements. • Monitor batch to batch variation though track and trend (Lot Review) analysis. • Completion of COA’s and lot specific forms for applicable products. • Highlight any issues/non-compliances and any threat to supply of product. • Calibration of appropriate QC equipment per relevant SOP and/or EOP. • Ensure the cleanliness and correct labelling of all QC equipment as per Standard Operating Procedures (SOP) and Equipment Operating Procedures (EOP. • Ensure cleanliness of the lab area and all work surfaces. • Adherence to the quality system and training given at all times. • Completion and review of Documentation to cGMP/GDP requirements/standards. • Flexibility and willingness to carry out overtime as necessary with advance notice. • Maintaining specified reference material quantities. • Raise change requests in a continuous effort to improve Quality Control records. • Assess changes through the Change Impact Assessment process. • Carry out training at individual or group level as required. Qualifications and Experience required for this role: • An advanced life science degree. • Minimum 2 years’ medical diagnostic/pharmaceutical experience. • Quality Control laboratory experience in biological sciences. • Demonstrated competence in biochemical techniques, statistical concepts, problem solving and root cause analysis. • Understanding of cGMP/GLP requirements and previous regulatory audit experience. • Experience and working knowledge of Microsoft Word/Excel and Minitab.
131 days ago