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.
Overview:
A fantastic and exciting opportunity has arisen for a Manufacturing Biotech Associate that will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement.
Requirements
Responsibilities:
* Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
* Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs and across our site that support our COMMIT culture.
* Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
* Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
* Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
* Routinely talk about any safety issues you are concerned about.
* Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
* Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
* Adhere to Right First-Time principles.
* Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
* Escalate issues as appropriate to manager/designee.
* Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
* Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
* Challenge and identify improvements to the safety and environmental programmes on site.
* Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
* Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
* Act as an ERT during emergency situation if trained .
* Maintain/ support a high standard of safety/ Good Manufacturing Practice (GMP) compliance at all times.
* Determine solutions by referencing relevant past experiences as part of problem solving activities.
* Get actively involved by participating in inspections, GEMBA's and Go-See's.
* Act as a team member on process deviation reviews and Gemba walkdowns.
* Mentor new members of staff in specific plant activities.
* Be prepared to answer auditor questions during site walkdowns.
* Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
* Utilize Lean Six Sigma Tools to support the initiative of continuous improvement (CI) projects to increase agility, flow, throughout and reduce cycle time and inventory.
* This is a 24/7 shift role