KBI
KBI: US - MS&T Data Reviewer I
USA - NC - Durham - Hamlin Rd
Sponsorship not specifiedDetected 30 days ago
ExcelCustomer SupportCollaborationWritingMicrosoft Office
About the role
- Make detailed observations and report documentation corrections to the relevant personnel, as needed.
- Job Responsibilities (Approximate % of Time):
- Ensures corrections are completed accurately. (20%)
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. (60%)
- 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. (20%)
- As needed, provide technical writing support for protocol and summary report technical documents. (10%)
- May require work outside of normal business hours to support critical regulatory deliverables or client interactions.
Requirements
- is a 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).
- Must have knowledge of GMPs and biotechnology-derived product regulations.
- Also requires a demonstrated track record in the following key areas:
- Photocopies, transcribes, and archives required documents, as appropriate. (5%)
Nice to have
- Strong orientation for quality and customer service
- Demonstrated level of respect for individuals
- High level of integrity and personal responsibility
- 1.2 Language Ability
- Ability to write routine reports and correspondence.
- Ability to communicate with coworkers and supervisors.
- 1.3 Reasoning Ability
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Skills
- 1.1 Knowledge, Skills, Abilities
- Strong collaboration and team building skills
Benefits
- Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Company info
- I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
Equal opportunity
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.