Quality Control Specialist

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 points 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: Quality Control Specialis t   ·         The purpose of this role is to work within and support the Global Development Quality Assurance team at client cite.   ·         This role will primarily provide support for Change Control, Deviation Management and Supplier Quality Management. ·         It will also support interface of SAP with IPI Product structure and MES BOMs and recipes.   Other activities to support Quality Systems and QA Operations will be required as per start up schedule. ·         The QA Systems and Compliance Team with work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the client Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems. Requirements The role is required to: Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.  Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely.  Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.  Provide QA oversight to GMP readiness, technical transfers, regulatory approvals and clinical operations at the facility.  Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required.  Assist in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements.  Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.  Ensure the escalation of compliance risks to management in a timely manner.      What skills you will need:   In order to excel in this role, you will more than likely have:    Bachelor’s degree, or higher (Science/Quality/Technical).  4-5 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.  Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation.  Strong written and verbal communication skills.  Ability to think logically and be proactive under the variable schedules of a startup site. Ability to work as part of a team and on own initiative in a constructive manner.  Strong attention to detail and precision in preparing and reviewing GMP documentation.  Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc. Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.    Desirable:  Experience in direct interactions with regulatory agencies during site inspection.  Previous experience working in a sterile/low bioburden environment.    #LI-KV1 Requirements The role is required to: Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones. Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility. Provide QA oversight to GMP readiness, technical transfers, regulatory approvals and clinical operations at the facility. Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required. Assist in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Ensure the escalation of compliance risks to management in a timely manner. What skills you will need: In order to excel in this role, you will more than likely have: Bachelor’s degree, or higher (Science/Quality/Technical). 4-5 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Strong written and verbal communication skills. Ability to think logically and be proactive under the variable schedules of a startup site. Ability to work as part of a team and on own initiative in a constructive manner. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc. Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Desirable: Experience in direct interactions with regulatory agencies during site inspection. Previous experience working in a sterile/low bioburden environment. #LI-KV1