Lab Sample Management Specialist

Title:: Lab Ops Specialist I 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 Bachelors 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