Description: 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

Job Types: Full-time, Contract

Pay: $25.00 - $30.00 per hour

Application Question(s):

• How many years of experience do you have with Quality control? (minimum 2 years)
• How many years of experience do you have in QC Sample Management? (minimum 2 years)
• How many years of experience do you have in LIMS? (minimum 2 years)
• How many years of experience do you have with Lab Operations? (minimum 2 years)
• Do you have a Bachelor's degree?

Work Location: In person