QC Chemistry Analyst

Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Job Title: QC Chemistry Analyst   Role Description: ·         A fantastic QC Chemistry Analyst opportunity for candidates interested in a new challenge in a cGMP regulatory environment. ·         The QC Analyst / Senior Technician Quality Control will report directly to the QC Chemistry Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing. The team works a 2-cycle shift pattern. ·         The ideal candidate will have 2- 3 years’ experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products. ·         The candidate will contribute to the positive culture by providing an inclusive environment to enable team members to achieve their best work. Requirements Role Functions: ·         Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. ·         Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc ·         Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same ·         Operate as part of the QC team performing the allocated testing and laboratory-based duties. ·         Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements ·         Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved ·         Participate in the laboratory aspects of OOS investigations ·         Provide support with audit/inspection requirements to ensure department compliance/readiness. ·         Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility. ·         Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 whys etc, ·         Work collaboratively to drive a safe and compliant culture.     Experience, Knowledge & Skills:   What skills you will need: ·         2-3 years of experience in a pharmaceutical laboratory ·         A good working knowledge of HPLC systems and software is desirable ·         A good knowledge of cGMP, GLP, Quality Management Systems   Initial Travel Requirements: ·         Occasional travel may be required for training purposes.   Qualifications & Education: ·         Bachelor’s Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline. #LI-KV2 Requirements Role Functions: · Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. · Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc · Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same · Operate as part of the QC team performing the allocated testing and laboratory-based duties. · Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements · Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved · Participate in the laboratory aspects of OOS investigations · Provide support with audit/inspection requirements to ensure department compliance/readiness. · Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility. · Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc, · Work collaboratively to drive a safe and compliant culture. Experience, Knowledge & Skills: What skills you will need: · 2-3 years of experience in a pharmaceutical laboratory · A good working knowledge of HPLC systems and software is desirable · A good knowledge of cGMP, GLP, Quality Management Systems Initial Travel Requirements: · Occasional travel may be required for training purposes. Qualifications & Education: · Bachelor’s Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline. #LI-KV2