Quality Documentation Specialist
Durham, North Carolina
Employer: Insight Global
Industry: QA
Salary: Competitive
Job type: Part-Time
We are currently is seeking a document reviewer for a large pharmaceutical manufacturing client in the Durham, NC area. The Document Reviewer will be responsible for the thorough examination of regulatory documents to ensure accuracy, completeness, and compliance with company standards and regulatory requirements. The ideal candidate will have a keen eye for detail and a strong understanding of pharmaceutical terminology and regulations.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Required Skills & Experience
- Bachelor's Degree in Science or related field
- 2+ years of experience in Quality or Documentation
- Reviewing cGMP documentation
- Knowledge of manufacturing processes for biologics, vaccines, cell or gene therapy products
Nice to Have Skills & Experience
- Experience with Veeva eQMS or BlueMountain software
- Previous experience supporting regulatory inspections
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Required Skills & Experience
- Bachelor's Degree in Science or related field
- 2+ years of experience in Quality or Documentation
- Reviewing cGMP documentation
- Knowledge of manufacturing processes for biologics, vaccines, cell or gene therapy products
Nice to Have Skills & Experience
- Experience with Veeva eQMS or BlueMountain software
- Previous experience supporting regulatory inspections
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Created: 2024-06-20
Reference: 362468
Country: United States
State: North Carolina
City: Durham
ZIP: 27703
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