Document Control Specialist

Sorrento Therapeutics San Diego , CA 92140

Posted 2 months ago

ABOUT US

Sorrento Therapeutics, Inc. is a clinical stage and commercial biopharmaceutical company focused on delivering innovative and clinically meaningful therapies to address unmet medical needs. Our vision is to leverage our proprietary G-MAB library in conjunction with proprietary targeted delivery modalities to generate the next generation of therapeutics for treating cancer, autoimmune, inflammatory, viral and neurodegenerative diseases. These modalities include proprietary chimeric antigen receptor T-cell therapy (CAR-T), dimeric antigen receptor T-cell therapy (DAR-T), antibody drug conjugates (ADCs), oncolytic virus (Seprehvec), lymphatic drug targeting (SOFUSA), as well as bispecific antibody approaches. We are additionally developing pain management solutions, including our clinical candidates resiniferatoxin (RTX) and SEMDEXA. In response to the global SARS-CoV-2 ("COVID-19") pandemic, we are also developing and conducting clinical studies for potential coronavirus antiviral therapies and vaccines, including Abivertinib, COVI-MSC, COVI-AMG, COVIDROPS, and COVI SHIELD, and diagnostic test solutions, such as COVISTIX and COVITRACK.

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!

Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations and guidance from the Safer Federal Workforce Task Force, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force's 2021 Guidance for Federal Contractors and Subcontractors (Updated November 10, 2021), available at:

WHAT WE ARE LOOKING FOR:

Sorrento Therapeutics ("Sorrento") is seeking an experienced Document Control Associate to join our team.

WHAT YOU'LL DO:

The Document Control Specialist is responsible for the document control system, including but not limited to change control, word processing, training and equipment database, and maintenance of documents, document site, coordination of periodic reviews of SOPs and archival of quality records. In addition, the Specialist shall lead or assist with investigations regarding all aspects of Quality Management as directed by a QA Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for maintaining an establishing a centralized Document Control System; ensure adequacy of procedures for assurance of document security, archival, retrieval and record retention.

  • Understand practical applications of cGMP phased approach and a Risk based Quality approach; write and update existing procedural documents to incorporate these approaches.

  • Give guidance and support all other departments on data integrity and Good Documentation/Manufacturing Practices.

  • Identify discrepancies and notify requestor and QA Management to ensure actions are taken in a timely manner to prevent deviations and non-conformances due to incorrect documentation.

  • Assist with preparation for FDA and other regulatory agency audits, inspections and customer audits (e.g. identify the correct document(s) requested, retrieve documents requested in a timely manner to prevent delays during audits/ inspections, interact with auditors regarding the Document Control System).

  • Assist in coordination of training activities for site.

  • Maintain and organize Training Files of all employees.

  • Organize, scan, create manifest list and archive other Quality Records, Laboratory Notebooks and GxP relevant documents such as Technical/Validation/Stability Protocols and Reports and batch records.

  • Coordinate the archival and retrieval of Quality Records with the offsite storage facility, as required.

  • Interact with all departments.

  • Assign lab notebooks, logbooks, lot numbers, product codes and document numbers as requested.

  • Maintain all Document Control logs.

  • Assist with all QA functions in the department, as needed.

  • Assist with special projects, internal investigations and internal audits as needed.

  • Other duties as assigned.

EDUCATION AND QUALIFICATIONS:

  • High School diploma or equivalent required, college coursework in science preferred but not required.

  • Minimum 3-5 years of work experience in the pharmaceutical or related industry, or equivalent combination of relevant education and experience.

  • Experience with both paper and electronic documentation systems or hybrid.

  • Basic email, Word, Excel, and web-based programs.

  • Knowledge of cGMP preferred.

  • Strong attention to detail.

  • Ability to follow standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

  • Good written and verbal communication skills.

  • Good organizational skills to prioritize tasks.

  • Ability to work on a team and independently.

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 equity-based compensation.

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 do not contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer.


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Document Control Specialist

Sorrento Therapeutics