QC Bioanalytical Analyst
3 weeks ago
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:
QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory
Requirements
Role Functions:
- Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, Compendials, UV, Raw Materials,DNA PCR and Bioassay ELISA testing in compliance with GMP requirements.
- Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and hygiene within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Promote and participate the implementation and maintenance of the relevant safety programs.
- 1 - 5 years laboratory testing experience in the Pharmaceutical industry.
- Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
- Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests.
- Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
- Knowledge of cGMP & Laboratory Quality Systems.
- Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
- Qualification in Science/Chemical Engineering/Biological Engineering
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