KBI: US - MS&T Data Reviewer I

KBI Biopharma • Durham, NC

3d • Onsite

About The Position

Perform data review for commercial program documents including Process Performance Verification (PPV) reports, Continuous Process Verification (CPV report) and any other reports supporting process validation for monoclonal antibodies, recombinant proteins, peptides and other biologics. This review includes the verification that calculations and documented information are correct, complete, and accurate in accordance with guidance documents and internal procedures. Make detailed observations and report documentation corrections to the relevant personnel, as needed.

Requirements

• Bachelor of Science degree in a scientific discipline with experience with data review and/or Manufacturing/Lab experience. (B.S. and 3+ years of experience or M.S. and 1+ years of experience).
• Knowledge of GMPs and biotechnology-derived product regulations.
• Strong orientation for quality and customer service
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility
• Strong collaboration and team building skills
• Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to communicate with coworkers and supervisors.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute ratio and percent.
• MS Teams, Outlook, Word, Excel, and PowerPoint.
• Computer, telephone, lab equipment

Nice To Haves

• Familiarity with Unicorn, JMP or other statistical software is a plus.

Responsibilities

• Performs timely and critical review of manufacturing and analytical data to ensure all data, calculations, and documented information are present, complete, accurate, and compliant.
• Adds comments and edits to applicable documents to identify incomplete/inaccurate data and other errors. Routes documents for additional review and corrections as needed. Ensures corrections are completed accurately.
• Photocopies, transcribes, and archives required documents, as appropriate.
• Provide technical writing support for protocol and summary report technical documents.
• Reacts to change productively and handles other essential tasks as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level