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, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients’ expectations regarding the 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 cooperatively 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:
1. Performs any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation RFT and technical writing.
2. 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.
3. Clearly demonstrates the organizational skills to manage all aspects of a given assay e.g., controls/reference, standard stock control, etc.
4. Ensures SOPs/forms are up to date with the latest requirements and improvements/optimizations/lean.
5. Supports process simulations and works as part of a team.
6. Demonstrates awareness of safety for self and others in all aspects of work. Understands analysis of data generated in the lab.
7. Maintains laboratory housekeeping standards.
8. Must have strong scientific and GMP documentation skills.
9. Understands Pharmacopoeias and guidelines and how to find and follow relevant information.
10. 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.
11. 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
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