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Laboratory Operation Specialist

3 months ago

Santa Monica, United States Fladger Associates Full time

Description: Lab Ops Specialist I

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)
- 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 Type**: Contract

Pay: $22.00 - $31.20 per hour

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance

Schedule:

- Day shift

**Experience**:

- Quality control sample management: 2 years (required)

Work Location: In person