OVERVIEW:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients that researches develop, and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.    

DESCRIPTION: 

REVISED DESCRIPTION: QC ANALYTICAL 

• Conduct analytical assays based on DNA extraction, qPCR, ELISA in a regulated GMP laboratory. 
• Author and revise processes and procedures for analytical methods and associated workstreams. 
• Follow procedures for purchasing, implementation, and maintaining QC equipment in collaboration with method subject matter experts 
• Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines 
• Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures 
• Support deviations, investigations, CAPAs, and change control activities as needed 
• Identify and lead teams for lean improvement activities 
• Support inspection readiness activities 
• Participate in generating training module and instruction led training material

MINIMUM REQUIREMENTS: 

• Bachelor's degree required; Masters preferred 
• 1-2 years of experience working in a pharmaceutical or biotech environment  cGMP experience 
• Experience in analytical testing, such as PCR, Flow Cytometry, ELISA, or other cell-based assays

TEKWISSEN® GROUP IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER (M/F/D/V) SUPPORTING WORKFORCE DIVERSITY.