Lab Ops Specialist I

Lab Ops Specialist I

Location: Monica, CA

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

We are seeking a highly motivated individual to join us as a Lab Ops Specialist I in Quality Control Sample Management in Santa Monica, CA.

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