Responsibilities:

• Perform 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 state
• Perform Cryo sample disposition and shipment
• Track inventory of lab supplies and materials
• Track inventory of retain samples, stability samples, test materials
• Track and distribute samples according to Stability protocols
• Troubleshoot standard issues and identify when a deviation from standard process occurs
• Gather metric information for use in continuous improvement of areas of responsibility
• Data entry and review
• Support generation of CoAs for product release
• Revise and review SOPs, work-instructions, forms, sampling plans
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Assist with audits, walkthroughs, inspections, when necessary
• 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

Additional Details

• Manager's Requested Bill Rate : (No Value)
• Onsite Offsite : Onsite

Job Type: Contract

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• Do you have experience in Quality Control/GMP Environment?
• Do you have experience in Sample Management?
• Do you have experience in performing QC sample receipt, processing and distribution for testing and storage?

Work Location: In person