Job Title: QC Analyst, Small Molecules
To support all Laboratory Quality Control activities related to the analytical method transfer in support of New Product Introductions (NPI) and to assure compliance with applicable regulations as well as company policies and procedures at Grange Castle Small Molecules facilities.
Key Responsibilities:
* Support quality control processes for small molecules laboratories in activities related to analytical method transfer (AMT): protocol review, analytical testing, execution of transfer protocols, QC batch data review, transfer report drafting, scheduling protocol execution/testing, working with method transfer lead, supporting Laboratory Investigation Record (OOS/OOT) and general Deviation/CAPA completion, QC SOP and Test Method drafting/update/review, general laboratory systems support and troubleshooting.
* Become Subject Matter Expert (SME) in a range of laboratory operations in support of method transfers for NPI, training other QC analysts where required.
* Ensure all laboratory equipment is maintained and calibrated as required.
* Support lab scheduling and perform laboratory testing by exception, where required.
* Develop required documents, including SOPs, specifications, and forms for QC systems and processes, in conjunction with QC Executive Site Quality Control Head or designees.
* Liaise with QC, QA, IT, and Manufacturing Operations departments in performance of normal duties and end user compliance across all areas.
* Investigate non-conformances, accidents, or other abnormal occurrences.
* Maintain safety standards to ensure safe working laboratory environment.
* HIGHLIGHT AND IMPLEMENT NEW TECHNOLOGIES IN QC AREA.
* Prepare for and support external audits (HPRA, FDA, corporate, client).
* Implement and adhere to data integrity guidelines for QC based systems.
General Responsibilities:
* Participate in cross-functional training initiatives.
* PROMOTE CORPORATE VALUES OF TAKEDA-ISM WITHIN WORKPLACE.
* Foster safety awareness culture in cooperation with other TIL staff.
* Complete Accident Reports/Near Miss Forms in a timely manner after an event.
* Complete all SOPs, reading, training, and assessments in a timely manner.
* Perform other duties as required and directed by relevant Manager or other Officer appointed by Board of Directors.
Educational Requirements:
* Minimum BSc Degree (life science).
* Practical experience working in GMP QC Laboratory (minimum 2 years).
Relevant Experience:
* Previous experience testing small molecule Drug Product or API general techniques required, e.g. Dissolution, Assay/Impurities by HPLC/GC, Moisture content by Karl Fischer, general wet chemistry techniques.
* Experience with Small Molecule Analytical Method Transfers, specifically HPLC/GC methods advantageous.
* Experience reviewing and writing SOPs and transfer/validation protocols and reports advantageous.
* Previous experience Empower advantageous.
Skills/Competencies:
* Good project management.
* Good time management.
* Good motivation ability work own initiative required.
About Us:
We transform patient care through development of novel specialty pharmaceuticals best in class patient support programs.
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