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.
Overview: To perform day to day laboratory testing, data review, routine duties and capable of enthusiastically taking responsibility for ad-hoc duties and projects.
While working co- operatively as part of a team, will demonstrate drive, initiative and hunger for knowledge and quality of work.
Will be, or demonstrate the capability of being, a Subject Matter Expert in several assays.
Ensures that laboratory objectives are effectively achieved consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Requirements Role Functions: Performs any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation RFT and technical writing Performs data review of microbiological test data from utilities and environmental monitoring samples.
Other data review may be performed in line with experience level and SME knowledge Clearly demonstrates the organisational skills to manage all aspects of a given assay e.g.
; controls/reference, standard stock control etc.
Ensures SOPs/forms are up to date with latest requirements and improvements/optimizations/lean.
Supports process simulations Works as part of a team Demonstrates awareness of safety for self and others in all aspects of work.
Understands analysis of data generated in the lab.
Maintains laboratory housekeeping standards Must have strong scientific and GMP documentation skills.
Understands Pharmacopoeias and guidelines and how to find and follow relevant information Required to comply with Global and regulatory Requirements and execute current good manufacturing practices (cGMP) in the performance of day to day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture, may be required to perform other duties as assigned.
Skills and Knowledge: Typical Minimum Education: Diploma or higher preferred; ideally in a related discipline Typical Minimum Experience: Would typically have prior related work experience; ideally in a Microbiology Laboratory setting Core Competences: Technical: Knowledge of cGMP and GDP preferred Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Understanding of Lean six Sigma Methodology preferred Business: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Flexible approach Leadership: Focus on Customers and Patients Collaborate Act with Candor and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent Demonstrate Ethics and Integrity Reports to: Microbiology laboratory Manager Shift Cycle: 2 Cycle Shift #LI-AM1 Requirements Would typically have prior related work experience; ideally in a Microbiology Laboratory setting 2 Cycle Shift To perform day to day laboratory testing, data review, routine duties and capable of enthusiastically taking responsibility for ad-hoc duties and projects.
While working co- operatively as part of a team, will demonstrate drive, initiative and hunger for knowledge and quality of work.
Will be, or demonstrate the capability of being, a Subject Matter Expert in several assays.