QA Specialist

· San Diego, California
Employment Type Full-Time
Compensation DOE+Benefits+Options

ABOUT US

 

Sorrento Therapeutics Inc. is a fast growing, clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its' extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir®").

 

We attract smart people who play well with others. We're small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career.

 

If you’re a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you!

 

WHAT WE ARE LOOKING FOR:

 

The QA Specialist’s responsibilities are divided into three primary functional areas: Raw Material Inspection and Release, Label Generation, and Document Control.

  • Raw Material Inspection: Associate is responsible for inspecting in-coming raw materials, releasing raw materials, obtaining and submitting test samples to the appropriate contract laboratory, and coordination of receipt of test results
  • Label Generation: Associate is responsible for ordering label and ribbon stock, generating Master Label templates from approved label specifications, producing labels for specific product lots, ensuring labels are verified as correct and are released in time to meeting the manufacturing schedule
  • Document Control: Associate is responsible for document control system, including but not limited to change control, word processing, training and equipment database, and maintenance of documents and document site; in addition, the associate shall assist with investigations as directed by QA Management; assist in the execution of validations, or other duties assigned by the head of QA

 

WHAT YOU’LL DO:

 

  • Responsible for inspecting in-coming raw materials, releasing raw materials, obtaining and submitting test samples to the appropriate contract laboratory, coordinating receipt of test results
  • Asist in establishing a centralized Document Control System. Ensure adequacy of procedures for assurance of document security, archival, retrieval and record retention
  • Assist in generation of SOPS and other documents; cross reference documents and evaluate the impact of changes on documents; review Document Change Requests with attention to detail, cross check documents to prevent discrepancies between documents; assist with periodic review of all SOPs and other procedural documents to ensure that documents reflect current practices
  • Work with other documents to review documentation for possible improvements or efficiencies; follow up to ensure document updates identified are completed in a timely manner
  • Identify discrepancies and notify requestor and QA Management to ensure actions are taken in a timely manner to prevent deviations and no-conformances due to incorrect documentation
  • Assist in establishing procedures for the generation, revision, and control of new and revised GXP documents; assign document numbers, track and trend document updates, verify documents are initiated using the correct template
  • Assist with preparation for FDA and other regulatory agency audits, inspections and customer audits
  • Maintain and organize Training Files of all employees
  • Scan GXP documents prior to being shipped the customer or offsite storage facility
  • Assist with special projects, internal investigations and internal audits as needed
  • Give guidance and support all other departments on data integrity and Good Documentation/Manufacturing Practice
  • Provide assistance during ISO, FDA, and customer audits
  • Assist with preparation for FDA and other regulatory agency audits, inspections and customer audits
  • Prioritize work in alignment with company priorities.
  • Assist with all QC/QA Functions in the department, as needed

 

EDUCATION AND QUALIFICATIONS:

 

  • AA or BS degree preferred in a science discipline but not required (e.g. Life Sciences, Chemistry, Biology, Microbiology)
  • Recommended 1-2 years of experience in the pharmaceutical or related industry
  • Hands-on experience with a paper Document Control System required
  • Experience with both paper and electronic or hybrid systems preferred
  • Strong knowledge of GMPs required
  • FDA and/or other regulatory agency experience
  • Strong GMP background is required; Experience with handling documents during ISO, FDA, inspections and/or other regulatory agency inspections is highly desired
  • Strong writing and verbal communication skills, specifically in technical writing communications and oral presentations
  • Must be very detail oriented and be able to quickly detect errors within documentation.

 

YOUR REWARD:

  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer. 
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, company paid holidays, and three-weeks’ PTO, plus stock options.

 

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you! 

 

Principals only. Recruiters, please don't contact this job poster. 

 

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

 

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  • Location
    San Diego, California
  • Employment Type
    Full-Time
  • Compensation
    DOE+Benefits+Options