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 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 to 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Requirements
Responsibilities:
* Support laboratory operations within the new laboratory facility, including equipment qualification (PQ), documentation generation of SOPs, Work instructions, and contributing to lab and process establishment.
* Review, trending, and reporting of laboratory data to support generation of batch data, maintain oversight of review metrics, and collate and analyze end of quarter and year reports for all raw data generated. Maintain and release laboratory stock and order laboratory consumables where required.
* Manage and ensure routine cleaning of laboratory equipment is completed as per site procedures and maintain laboratory housekeeping standards, identifying continuous improvement opportunities in laboratory processes.
* Respond to standard requests from partners, customers, and clients (internal and/or external).
* Participate in functional meetings and facilitate cross-functional meetings where required.
* Participate in laboratory investigations and Root Cause Analysis activities.
* Participate in internal and external audit and inspection activities.
* Participate in SME development groups to improve technical expertise.
* Support site safety culture.
* Perform supporting activities for general lab operations, EM, facility testing, method transfers, method verifications, and execution of laboratory studies as required.
* Possess a good knowledge of GMP, familiarity with USP, EP, JP requirements.
* Support the introduction of novel, innovative solutions, supporting the testing of biologics within the facility.
* Participate in risk assessments as required.
* Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve, and develop.
* Exhibit excellent troubleshooting and problem-solving skills as an individual contributor as well as collaboration skills and teamwork ability with global and interdisciplinary teams.
* Support the culture of the client's ways of working.
* Build team effectiveness skills, learn to promote team success through own actions and by demonstrating respect and appreciation for diverse populations.
* Support timely training completion and coaching of team members.
* Be flexible to support changing business needs (e.g. infrequent out of hours testing support for exceptional circumstances).
* Act as a group representative at cross-functional meetings.
Experience, Knowledge & Skills:
* Ability to work as part of a team and on own initiative in a constructive manner.
* Knowledge of Biologics manufacturing and familiarity with microbiological testing techniques.
* Knowledge of laboratory systems (e.g. LIMS, E-logs, MODA, and electronic notebooks).
* Ability to think logically and be proactive under pressure.
* Effective communicator with technical expertise in science, able to share and communicate that knowledge through training other analysts.
* Support site culture.
Qualification:
* A degree qualification in a relevant field (Biological Sciences/Engineering), preferably with a background in microbiology.
* A minimum of 1-3 years experience working in a relevant academic or industry field (Internships and student placements will be considered in lieu of experience).
* Experience in Microbiology is a must.
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