Job Description About PSC Biotech Who are we?
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.
An amazing opportunity has arisen for a QC Analyst in Analytical Testing in our new state of the Art single use Multiproduct Biotech facility.
In our start-up site the role will be responsible for Quality Control testing and all associated laboratory activities related to Biochemistry and Analytical Methods.
What you will do: Bring energy, knowledge, innovation and influence to carry out the following: Perform a variety of routine Analytical techniques and associated documentation; including but not limited to Capillary Electrophoresis, UPLC, HPLC, GC, Wet Chemistry methods in compliance with GMP requirements · Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation · Drive the development of technical skills through coaching and motivate a high performing culture across the team · Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities · Consistently deliver on specific area Key Performance Indicators Operate to the highest standards of Safety, Quality and Compliance Demonstrate a commitment to learning and personal development that supports Quality, EHS, L&D and continuous improvement Requirements What skills you will need: In order to excel in this role, you will more than likely have: Degree qualification (Science/Quality/Technical) 1-3 years' experience in the biotechnology and/or pharmaceutical industry, particularly in relation to Capillary Electrophoresis, UPLC, HPLC or GC testing Preferably Lean Six Sigma experience Ability to think logically and be proactive under pressure Ability to work as part of a team and on own initiative in a constructive manner Flexible and self-motivated Requirements Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
Support implementation and training for site Quality Systems and site GMP readiness activities.
Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
Support other QA colleagues, as required.
Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.