Top 186 Author Jobs in Raleigh, Nc

GMP Compliance Investigator
Medasource —Durham, NC
- $33 - $38 an hour
- Full-time
- Mid-level
- Master's degree
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
13d
Library Assistant
St. David's School —Raleigh, NC
- Full-time
- Teaching
- Entry level
Quick Apply
4d
Editor
PENDIUM Publishing House —Raleigh, NC
- Email
- Writing skills
- Mid-level
- Communication skills
- Work from home
Instructional Technologist
Western Governors University —Raleigh, NC
- $66,800 - $100,100 a year
- Full-time
- Azure
- Mid-level
- Office
- Health savings account
- Paid holidays
QC Microbiologist (Endotoxin/Bioburden/EM)
Bwiz Solutions —Holly Springs, NC
- $25 - $30 an hour
- 10 hour shift
- Mid-level
- Bachelor's degree
- In-person
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Executive Assistant (Raleigh, North Carolina)
Drucker and Falk LLC —Raleigh, NC
- Overtime
- Microsoft Outlook
- Computer literacy
- Writing skills
- Disability insurance
- Health insurance
8d
Associate II, Quality Control Microbiology
Biogen —Research Triangle Park, NC
- $57,000 - $74,000 a year
- Full-time
- Bachelor's degree
- Entry level
- Under 1 year
- Paid parental leave
- Employee stock purchase plan
5h
Technical Content Developer, Cloud
Accenture —Raleigh, NC
- $59,100 - $154,800 a year
- Full-time
- Hybrid work
- Azure
- Mid-level
- AWS
- Paid holidays
- Disability insurance
Pharmacovigilance Specialist - US - Remote
Worldwide Clinical Trials —Durham, NC
- $50,000 - $99,000 a year
- Full-time
- Nursing
- Computer literacy
- English
Field Project Manager, Critical Power Systems
SMT INC —Raleigh, NC
- Full-time
- Remote
- CPR Certification
- Up to 50% travel
- Construction site
- Paid holidays
- Disability insurance
Quick Apply
9h
Cyber Software Engineer (TG)
Northrop Grumman —Raleigh, NC
- $96,300 - $151,400 a year
- Overtime
- Computer Science
- Windows
- Java
- Paid holidays
- Disability insurance
Examination Editor I
American Board of Anesthesiology Inc —Raleigh, NC
- Weekends as needed
- Writing skills
- Office
- Bachelor's degree
Quick Apply
1d
The Technical Document Specialist/Sr. Technical Document Specialist
Grifols —Clayton, NC
- Full-time
- Bachelor of Science
- Mid-level
- Office
Consultant, Clinical Outcomes Assessment
Parexel —Raleigh, NC
- $119,440 - $179,160 a year
- Email
- Office
- 3 years
- Master's degree
- Referral program
12d
Senior Specialist – Investigations & Regulatory Inspections
Amgen —Holly Springs, NC
- $137,263.10 - $185,708.90 a year
- Doctoral degree
- Engineering
- Master's degree
- Disability insurance
- Health insurance
Sr. Manufacturing Specialist I
Biogen —Research Triangle Park, NC
- $98,000 - $127,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Senior level
- Paid parental leave
- Employee stock purchase plan
1d
Project Program Management Senior Manager
CVS Health —Raleigh, NC
- $67,900 - $182,549 a year
- Full-time
- HIPAA
- Bachelor's degree
- Fair chance
- Health insurance
- Dental insurance
Senior Medical Editor - Healthcare Marketing
Precision Medicine Group —Raleigh, NC
- $70,000 - $98,000 a year
- Online Application
- Remote
- English
- 3 years
- Mentoring
- Opportunities for advancement
8d
Sr. Quality Associate I, Quality Assurance
Grifols —Clayton, NC
- Full-time
- 5 years
- Bachelor of Science
- Mid-level
Innovation Lead - Office of the CTO | AI (10342)
Extreme Networks —Raleigh, NC
- $200,000 - $230,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Office
- Employee stock purchase plan
- Paid holidays
Quick Apply

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GMP Compliance Investigator

Medasource -
Durham, NC

Quick Apply

Job Details

Full-time | Contract
$33 - $38 an hour
13 days ago

Benefits

Health insurance
Dental insurance
Vision insurance

Qualifications

Biology
Teamwork
Manufacturing facility experience
Bachelor's degree
Organizational skills

Full Job Description

GMP Compliance Investigator – Equipment & Facilities

Contract: 6 months

Schedule: M-F 8-5 onsite at Marcus Center in Durham

Overview

Our client is seeking a GMP Compliance Investigator – Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering closely with Manufacturing and Quality teams.

This is a highly collaborative role for someone with strong GMP quality experience, exceptional technical writing skills, and the ability to manage complex investigations from initiation through closure.

Responsibilities

Develop, revise, and maintain Standard Operating Procedures (SOPs) to ensure compliance with FDA and applicable regulatory requirements.
Author and manage change controls related to SOP updates and manufacturing process improvements.
Edit batch records and manufacturing documentation as needed.
Initiate, investigate, author, and close deviations, CAPAs, investigations, and quality memos.
Partner with Manufacturing and Quality teams to investigate manufacturing events and drive timely closure of quality records.
Serve as the primary author for equipment and facility-related deviation investigations.
Attend meetings with equipment vendors and internal stakeholders to gather information supporting investigations.
Author validation documentation, including IQ, OQ, and PQ protocols, equipment assessments, and validation reports.
Manage deviation, CAPA, and change control timelines to support on-time batch release.
Perform failure mode analysis and root cause investigations.
Support batch release activities from a compliance perspective.
Ensure compliance with FDA regulations and applicable accreditation standards.
Train and educate personnel on updated procedures, SOPs, quality systems, and compliance requirements.
Assist during FDA, accreditation, sponsor, and regulatory inspections, including responses to audit observations.
Monitor Quality Agreements to ensure sponsor notification requirements are met.
Participate in continuous improvement initiatives to optimize quality systems and documentation processes.

Preferred Qualifications

Experience working in a Quality Assurance or GMP Compliance function within an FDA-regulated manufacturing environment.
Experience supporting deviations, investigations, CAPAs, and change controls.
Strong technical writing skills with experience authoring investigation reports and SOPs.
Experience participating in FDA inspections, regulatory audits, and sponsor audits.
Experience with electronic Quality Management Systems (QMS).
Project management experience.
Strong analytical and root cause investigation skills.
Excellent written and verbal communication skills.
Strong organizational skills with exceptional attention to detail.
Ability to work independently while collaborating effectively across cross-functional teams.

Minimum Qualifications

Education - Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.

Experience

Minimum of 6 years of Quality Assurance, Quality Systems, or GMP Compliance experience within a regulated manufacturing environment.
A Master's degree in a related field may substitute for two years of experience.

Pay: $33.00 - $38.00 per hour

Benefits:

Dental insurance
Health insurance
Vision insurance

Application Question(s):

Do you have experience authoring investigations, deviations, CAPAs, change controls, SOPs, and validation documentation?
Have you personally owned deviations/investigations from initiation through closure?
Do you have QA/Compliance experience supporting regulated GMP manufacturing?

Education:

Bachelor's (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

author jobs in raleigh, nc

GMP Compliance Investigator

Library Assistant

Editor

Instructional Technologist

QC Microbiologist (Endotoxin/Bioburden/EM)

Executive Assistant (Raleigh, North Carolina)

Associate II, Quality Control Microbiology

Technical Content Developer, Cloud

Pharmacovigilance Specialist - US - Remote

Field Project Manager, Critical Power Systems

Cyber Software Engineer (TG)

Examination Editor I

The Technical Document Specialist/Sr. Technical Document Specialist

Consultant, Clinical Outcomes Assessment

Senior Specialist – Investigations & Regulatory Inspections

Sr. Manufacturing Specialist I

Project Program Management Senior Manager

Senior Medical Editor - Healthcare Marketing

Sr. Quality Associate I, Quality Assurance

Innovation Lead - Office of the CTO | AI (10342)

I want to receive the latest job alert for author in raleigh, nc

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