Analytical Science & QC Specialist

OBJECTIVES:Analytical Science & Quality Control (QC) Specialist is responsible for day-to-day QC laboratory operational activities and program / product analytical method transfer to ensure compliance of introduced analytical methods to current standards during both Drug Substance (DS) and Drug Product (DP) manufacturing at a scale appropriate for clinical trial stage R&D/CMC development operations and GMP manufacturing operations. The incumbent provides data trending and statistical support for periodic reporting including investigations for quality incidents e.g., OOS, deviations, CAPA in accordance with Hilleman Quality Policy, Standards and SOPs. RESPONSIBILITIES: GeneralGeneral lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc Establish QC procedures by drafting and reviewing QC functional SOPs including QC testing SOPs.Perform testing, documentation and review of results in accordance with current Good Manufacturing Practices (cGMP) and ProceduresPerform timely completion of testing and reporting of test results in support of manufacturing operations. Train other analysts on methods and/or SOP. Participate/ support in QC or cross functional projects e.g., equipment qualification, method validation, method transfer, process improvement projects. Support in equipment qualification and technical selection of QC equipment and/or standards and reagents. Troubleshoot of analytical equipment and assist in the identification and resolution of equipment issues.Problem solving of testing related issues as well as troubleshooting of equipment. Perform assessment for lab related deviations and identify corrective actions where necessary. Work with tech transfer teams to prepare new processes; point of contact for QC/lab operations for external customers. Set-up and coordinate detailed planning and document deliverables as per Master Plan and agreed timelines by working collaboratively within QC and cross-functional teams.Participate in process improvement initiatives to enhance efficiency and product quality. Lead/support quality incident e.g., OOx/ deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.Environmental Monitoring, Sterility and MicrobiologyResponsible for Environmental Monitoring (Viable and Non-Viable) of cleanrooms, water and gases as per SOPs.Responsible for coordinating Microbiological Testing of water/ raw material/ in-process/ finished product / stability/validation/utility samples as per approved SOPs.Responsible for coordinating GPT, Sterility Testing and Microbial Identification.Technical support as Subject Matter Expertise for Microbial and Contamination Control Topics.Work with other teams to improve processes and systems, growing the Sterility Assurance Level (SAL)Support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.Support to develop sterility assurance principles, focusing on aseptic processing and contamination control.Support compliance with microbial control standards, including Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM), Sterilisation methods, and Aseptic process simulations (APS) Sample Testing LogisticsSupport Sample Management functions for sample planning and sampling executionResponsible for disposition of samples upon confirmation.Raw MaterialsProvide technical support in the creation of Raw Material Risk Assessments and Raw Material Specification. Responsible for coordinating Raw Material testing.Perform Raw Material Quality Inspections on the ERP systemIn-Process and Release TestingResponsible for coordinating Raw Material testing.Report In-Process and Release Testing to enable timely product release. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Basic Qualifications:Bachelor’s degree / Diploma or equivalent, preferably in science, engineering or other related technical field.Minimum of 3-7 years of relevant experiences, preferably in Quality Control, Analytical Science & Technology, Manufacturing including drug substance, fill/finish operations, or related field in the pharmaceutical industry (preferably vaccines or biologics industry).Experience in QA/QC Sterile processing and microbial work. Shown good understanding of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing, and microbiological control strategy required.Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical resultsGood knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behaviour. Familiar with regulatory requirements and local Codes & Standards especially in vaccines and biologics e.g., FDA, EMEA and ICHQ7Preferred Key Skills, Abilities, and Competencies: The role should possess in good understanding of the relevant regulatory environment, including applicable regulations and current guidelines for manufacture of medicinal products.Knowledge and understanding of microbiology, analytical testing, QC systems and contamination control strategy.Knowledge and experiences with GMP laboratory operations, data integrity requirements and associated laboratory equipment. Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipmentGood verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management.Ability to coordinate actions with multi-functions to ensure that the overall Hilleman quality requirements are met. Experience in working with internal and external multifunctional teams. Partner and influence other departments and functions throughout the organizations to implement ongoing product / process robustness to continuously improvement.