Top 82 Document reviewer Jobs in Raleigh Nc

KBI: US - MS&T Data Reviewer I
KBI Biopharma —Durham, NC
- Full-time
- Microsoft Outlook
- Bachelor of Science
- Basic math
Healthcare Customer Care Specialist- Cary, NC
Kuehne+Nagel —Cary, NC
- $20 - $23 an hour
- US work authorization
- Data entry
- Experience equivalent to degree accepted
- Health insurance
- 401(k)
PLAN REVIEWER
JDS Consulting, PLLC —Raleigh, NC
- $60,000 - $70,000 a year
- Full-time
- Microsoft Outlook
- Residential
- Organizational skills
- Paid holidays
- Health insurance
Quick Apply
Complaint Reporting MDR/Vigilance Specialist 2
Teleflex —Morrisville, NC
- $73,000 a year
- Background check
- Nursing
- Microsoft Excel
- Paid parental leave
- Health savings account
Quick Apply
Pharmaceutical Development Scientist I
CATO SMS —Cary, NC
- Full-time
- Bachelor of Science
- English
- Mid-level
Quick Apply
QC Tech IV
Par Health —Raleigh, NC
- 12 hour shift
- 5 years
- Computer literacy
- Bachelor of Science
Quality Lead (Product Complaints)
GlaxoSmithKline —Zebulon, NC
- Full-time
- 3 years
- Continuous improvement
- Travel
Associate Medical Affairs Operations Manager
United Therapeutics —Research Triangle Park, NC
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid parental leave
- Employee stock purchase plan
5d
Examination Editor II
American Board of Anesthesiology Inc —Raleigh, NC
- Weekends as needed
- Writing skills
- Mid-level
- Bachelor's degree
Quick Apply
Staff Industrial Hygienist
Terracon —Raleigh, NC
- Mid-level
- Master's degree
- Driver's License
- Paid holidays
- Health insurance
Senior Administrative Project Coordinator - Architecture
HDR —Raleigh, NC
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
Project Surveyor
Hillpointe —Raleigh, NC
- Remote
- Ability to walk for extended periods
- Research
- Office
Quick Apply
Substation Designer- Physical
WESTWOOD PROFESSIONAL SERVICES INC —Raleigh, NC
- $90,000 - $110,000 a year
- Full-time
- Civil engineering
- Mid-level
- Office
Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs
Merz Aesthetics —Raleigh, NC
- Full-time
- 5 years
- English
- Office
Sr. Medical Writer (Regulatory)
サイネオス・ヘルス —Morrisville, NC
- $80,600 - $145,000 a year
- Travel
- Mentoring
- Senior level
- Employee stock purchase plan
- Health insurance
Medical Writer II/ Sr Medical Writer
サイネオス・ヘルス —Morrisville, NC
- $70,100 - $145,000 a year
- English
- Mid-level
- 3 years
- Employee stock purchase plan
- Health insurance
Associate Director, Medical Affairs, Southeast
TSP (A Syneos Health Company) —Raleigh, NC
- Medicine
- Driver's License
- Doctor of Philosophy
Manager, Environmental Operations
Quanta Infrastructure Solutions Group, LLC —Raleigh, NC
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
- Paid parental leave
- Health savings account
Staff Engineer
Terracon —Raleigh, NC
- Engineering
- Laboratory experience
- Mid-level
- Paid holidays
- Health insurance
Solutions Architect
United Therapeutics —Research Triangle Park, NC
- Full-time
- Azure
- Computer Science
- 3 years
- Paid parental leave
- Employee stock purchase plan

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KBI: US - MS&T Data Reviewer I

KBI Biopharma -
Durham, NC

Apply Now

Job Details

Full-time

Qualifications

Biotechnology
Laboratory instruments
Microsoft Outlook
Presentation software
Pharmaceutical regulatory compliance
Basic math
English
GMP
Microsoft Teams
Team building

Full Job Description

Job Summary:

Perform data review for commercial program documents including Process Performance Verification (PPQ) 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.

Job Responsibilities (Approximate % of Time):

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%)
Photocopies, transcribes, and archives required documents, as appropriate. (5%)
As needed, provide technical writing support for protocol and summary report technical documents. (10%)
Reacts to change productively and handles other essential tasks as assigned. (5%)

Job Requirements:

1.1 Knowledge, Skills, Abilities

Minimum requirement 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:

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

1.2 Language Ability

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.

1.3 Reasoning Ability

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.

1.4 Math Ability

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.

1.5 Physical Demands

See Essential Physical Functions table.

1.6 Computer Skills

MS Teams, Outlook, Word, Excel, and PowerPoint. Familiarity with Unicorn, JMP or other statistical software is a plus.

1.7 Equipment Use

Computer, telephone, lab equipment

Working Conditions:

May require work outside of normal business hours to support critical regulatory deliverables or client interactions.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

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. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Apply Now

Refine Your Search

document reviewer jobs in raleigh nc

KBI: US - MS&T Data Reviewer I

Healthcare Customer Care Specialist- Cary, NC

PLAN REVIEWER

Complaint Reporting MDR/Vigilance Specialist 2

Pharmaceutical Development Scientist I

QC Tech IV

Quality Lead (Product Complaints)

Associate Medical Affairs Operations Manager

Examination Editor II

Staff Industrial Hygienist

Senior Administrative Project Coordinator - Architecture

Project Surveyor

Substation Designer- Physical

Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs

Sr. Medical Writer (Regulatory)

Medical Writer II/ Sr Medical Writer

Associate Director, Medical Affairs, Southeast

Manager, Environmental Operations

Staff Engineer

Solutions Architect

I want to receive the latest job alert for document reviewer in raleigh nc

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