Kelly Services QC Lab Analyst - ELISA, San Diego, CA in San Diego, California

QC Lab Analyst - ELISA, San Diego, CA

Our client is seeking a Quality Control Analyst to work in the Regulatory, QA, & QC Department.

The Quality Control (QC) Analyst will perform all QC testing for release, stability and any cGMP related samples pertaining to manufacturing, study protocols or animal study in process.

Salary Range: Open depending on experience

Primary Duties and Responsibilities:

  • Perform all QC testing for release, stability and any cGMP related samples pertaining to study protocols or animal study.

  • Train on bioassay, allowing multiple personnel (outside of Manufacturing) as coverage.

  • Perform all ELISA qualification.

  • Provide as additional back-up for all Manufacturing testing (i.e. In-process ELISA testing during CCM collection/clarification/concentration).

  • Provide additional back-up for initial back up reviewer to allow sufficient time to review batch records prior to full review (this will allow immediate discovery of any possible discrepancy due to unforeseen errors during preparation or completing Manufacturing records upon distribution to QA for review).

Job Requirements:

  • Bachelor's degree in related field

  • Minimum of two (2) year of cGMP / FDA regulated environment, preferably pharmaceutical or biotech industry or relevant experience

  • Technical writing experience a plus.

  • Sound knowledge of cGMPs or equivalent regulations

  • Organizational and time management skills to coordinate multi-discipline projects.

  • Detailed oriented and proactive.

  • Excellent time management and ability to multi-task

  • Must be able to work in a fast-paced environment

  • Flexibility in problem solving and work hours to meet business objectives

  • Proven ability to work independently in hands-on laboratory setting

  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Project and Outlook, knowledgeable with styles, formatting, and ability to generate spreadsheets with applied knowledge of formula creation, charting and formatting

  • Excellent written and verbal communication skills

Physical Requirements/Working Environment:

  • Must be able to lift 50 lbs. on occasion

  • Must be comfortable working in a clean room Environment

  • Regularly required to operate standard lab and office equipment (e.g., personal computer)

  • Regularly required to use hands to operate laboratory equipment, computer and office equipment

  • Close vision required for computer usage

  • Occasional walking/standing for long periods of time to assist in environmental monitoring of the controlled rooms or to inspect/release incoming materials/components

  • Internal and External Working Relationships:

  • Professional Interaction with other employees working in Manufacturing, Engineering, Quality Assurance, Quality Control, Research and Development, Facilities and Purchasing

  • Interaction with technical and sales vendor representatives, contractors and regulatory authorities as deemed necessary

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.