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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 who 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.
Location : Santa Monica, CA 90404
Duration : 6 Months
Job Type : Contract
Work Type : Onsite
Description : Responsibilities
Responsibilities
Prform QC sample receipt, processing and distribution for testing and storage
Perform Apheresis Accession, Inspection, and assist QA with product returns
Maintain, operate equipment and instruments supporting sample processing
Work with internal resources to maintain lab in an optimal stat
Perform Cryo sample disposition and shipmen
Track inventory of lab supplies and material
Track inventory of retain samples, stability samples, test material
Track and distribute samples according to Stability protocol
Troubleshoot standard issues and identify when a deviation from standard process occur
Gather metric information for use in continuous improvement of areas of responsibilit
Data entry and review
Support generation of CoAs for product releas
Revise and review SOPs, work-instructions, forms, sampling plan
Monitor the GMP systems currently in place to ensure compliance with documented policies
Assist with audits, walkthroughs, inspections, when necessar
Additional duties as assigned
Basic Qualifications
Bachelor's Degree OR
AA Degree and 1 years of experience in Quality Control / GMP Environment OR
High School Degree and 3 years' experience in Quality Control / GMP Environment
Physical requirements : Ability to lift up to 30 lbs
Preferred Qualifications
Degree in biotechnology or related field with Quality Control experience
Working knowledge of GMP, SOPs and quality control processes
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11 / 210 / 211)
Proficient in MS Word, Excel, Power Point and other applications
Ability to communicate and work independently with scientific / technical personnel
Strong written and verbal communication skills
Comfortable in a fast-paced small company environment with direction and able to adjust workload based upon changing priorities
Experience with LIMS
Ability to work with a variable schedule
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Last updated : 2024-04-24
Full Time
Business Services
$66k-87k (estimate)
04/25/2024
05/01/2024
tekwissen.com
ANN ARBOR, MI
200 - 500
1998
Private
STEVE MOMORELLA
$10M - $50M
Business Services
TekWissen provides enterprise software, web development, data warehousing, systems integration, information technology security services.