Laboratory Operation support specialist

1 month ago


Santa Monica, United States Intelliswift Software Full time

Title: Laboratory Operation support specialist

Location: On-site Santa Monica, CA.

Hours/Days: (Tuesday-Sat) Flexible hours.

Duration: 06 Months assignment


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

• Associate 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



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