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 Technical Manager, QA reviews cGMP relevant documents. Focuses on implementation of the Quality Program and its continuous improvement to ensure compliance with phase appropriate cGMP. Assesses gaps during documentation reviews, KQI trending, Product Quality Reviews and proposes the need for improvements such as additional training on current applicable CGMP topics and industry standards. Organizes Management Review Meetings, training webinars, initiates procedures and policies required for the Implementation of Quality Program at Sorrento Therapeutics, Inc. and continuous improvement. Supports audits and inspections
WHAT YOU’LL DO
· Performs line clearances to ensure compliance to cGMPs.
· Ensures adequacy of procedures for phase appropriate cGMP compliance.
· Performs internal audits for assurance of cGMP compliance and adherence of STI guidelines and SOPs within STI operations. Creates and periodically updates internal audit plan.
· Communicates audit findings in a timely manner to the auditee and provides recommendations (as necessary). Writes internal auditreports and follows up on completion of any open CAPA deemed necessary that were communicated to the auditee.
· Assists in establishing procedures for the generation, revision, and control of new and revised GXP documents.
· Works with other departments to review documentation for other possible improvements or efficiencies. Update procedures as necessary and ensure documentation exists showing the completion of periodic document reviews.
· May assist with training on various cGMP topics e.g. Good Documentation Practices, USP<1224>, USP<1225>, USP<1226>, ICH Q1 and ICH Q2, Review of Analytical Documentation and Raw Data, SOP training, etc.
· Ensures that document, facility and equipment changes are tracked and any revalidation needs are assessed in accordance with applicable regulatory requirements, internal policies and procedures and phase appropriate cGMPs.
· Ensures that CAPAs address the Root Cause(s) and ensures a realistic timeline for implementation of CAPAs.
· Performs Effectiveness Checks by following up on closed CAPAs, Change Controls and Trainings. Reports recurrence of quality issues and/or excursions to Sr. Director, Quality Assurance in a timely manner.
· Interacts with all departments, works on ways to continuously improve current practices to meet quality plan, corporate goals and objectives.
· Assists in the preparation of meeting agendas and meeting minutes during Quality Systems Management Review Meetings and other important company meetings.
· Issues numbers for Quality Events, OOSs, Deviation Reports, NCMRs, CAPAs, etc.
· Follows up on open excursions to ensure timely completion of investigation reports.
· Assists with periodic review of all SOPs and other procedural documents to ensure that documents reflect current practices.
· Works with cross-functional teams to ensure all New Supplier Requests forms are submitted on time to QA for audit planning, creates audit agenda and coordinates audits with external suppliers.
· Updates Audit Plan on a periodic basis, maintains Supplier Audit Logs, Approved Supplier List to ensure that it is current.
· Follows up with suppliers on a periodic basis to ensure timely completion of paper audit and any Preliminary Supplier Evaluation.
· Prioritizes projects appropriately and with flexibility to accommodate changing corporate objectives.
· Performs other duties as assigned.