Junior QC Associate

3 weeks ago

india PSC Biotech Ltd Full time
Job Description
About PSC Biotech

 

 

Who we are?

 

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.


Job Title: QC Associate Junior ( Bio analytical Sciences  Intermediate)

 

Under minimal supervision, responsible for one or more of the following activities in QC including:

·        Reagent management, media preparation, GMP document review and management, sample and data management and some analytical testing.

·        Contributes to team by ensuring the quality of the tasks/services provided by self.

·        Contributes to the completion of milestones associated with specific projects or activities within team.

·        The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.

·        Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.


Requirements

Specific Job Duties:

·        With a high degree of technical flexibility, work across diverse areas within the lab

·        Plan and perform routine tasks with efficiency and accuracy.

·        Review, evaluate, back-up/archive, and approve analytical data.

·        Troubleshoot, solve problems, and communicate with stakeholders.

·        Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

·        Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

·        Approve lab results.

·        May participate in lab investigations.

·        May provide technical guidance.

·        May train others.

·        May contribute to regulatory filings.

·        May represent the department/organization on various teams.

·        May interact with outside resources.

 

Knowledge:

·        Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.

·        Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

·        Some/limited experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique

 

Skills:

·        Take initiative to identify and drive improvements.

·        Excellent verbal and written communication skills

·        Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

·        Presentation skills.

·        Escalate issues professionally and on a timely basis.

·        Decision Making skills.

·        Teamwork and Coaching others.

·        Negotiation and Influence skills.

·        Project Management and organizational skills, including ability to follow assignments through to completion.


Relevant Experience:

• Bachelor’s degree in a science discipline.

• 1-2 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.


#LI-KV1
Requirements
Specific Job Duties: · With a high degree of technical flexibility, work across diverse areas within the lab · Plan and perform routine tasks with efficiency and accuracy. · Review, evaluate, back-up/archive, and approve analytical data. · Troubleshoot, solve problems, and communicate with stakeholders. · Participate in audits, initiatives, and projects that may be departmental or organizational in scope. · Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. · Approve lab results. · May participate in lab investigations. · May provide technical guidance. · May train others. · May contribute to regulatory filings. · May represent the department/organization on various teams. · May interact with outside resources. Knowledge: · Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning. · Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery · Some/limited experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique Skills: · Take initiative to identify and drive improvements. · Excellent verbal and written communication skills · Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) · Presentation skills. · Escalate issues professionally and on a timely basis. · Decision Making skills. · Teamwork and Coaching others. · Negotiation and Influence skills. · Project Management and organizational skills, including ability to follow assignments through to completion. #LI-KV1

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