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 supports the QA team to ensure compliance with company procedures and applicable regulatory requirements, and supports manufacturing groups through the following activities:
- Line Clearance and Area Release: Specialist is responsible for ensuring cGMP manufacturing areas are set up correctly and free of materials not related to the process
- Batch Record Review: Specialist is responsible for reviewing executed batch records for accuracy, completeness, and cGMP compliance
- Management of Quality Events: Specialist is responsible for working with operations groups to assist with investigations and to ensure timely, accurate completion of deviations, nonconforming material reports (NCMRs) and corrective and preventive actions (CAPAs)
- Raw Material Inspection: Specialist is responsible for inspecting and releasing incoming raw materials
- Label Generation: Associate is responsible for ordering label and ribbon stock, printing product labels using approved templates, ensuring labels are verified as correct and are released in time to meet the manufacturing schedule
WHAT YOU’LL DO:
- Inspect and release incoming raw materials, perform line clearance and area release, and review batch records
- Assist in revision and authoring of SOPs and other documents; cross referencing documents and evaluating the impact of changes; cross check documents to prevent discrepancies; assist with periodic review of SOPs and other procedural documents to ensure that documents reflect current practices
- Identify deviations and nonconformances during raw material release, line clearance, and batch record review
- Assist with preparation for FDA and other regulatory agency audits, inspections and customer audits
- 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 Practices
- Prioritize work in alignment with company priorities.
- Assist with all QA Functions in the department, as needed, and perform other duties as assigned
EDUCATION AND QUALIFICATIONS:
- BS degree preferred in a science discipline but not required (e.g., Life Sciences, Chemistry, Biology, Microbiology)
- Recommended: 2 years of experience in QA in the pharmaceutical, biotech, or other regulated industry
- Experience with paper, electronic, or hybrid document management systems preferred
- Strong knowledge of cGMPs required
- FDA and/or other regulatory agency experience preferred
- Strong writing and verbal communication skills, specifically in technical writing communications and oral presentations
- Must have strong attention to detail while reviewing records.
- 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