JSG has a client in Durham ND looking for a Documentation Specialist - I (Assistant)
This hands-on position offers the opportunity to contribute to high standards of GMP and GDP compliance, ensuring our operations run smoothly and inspection-ready. If you're detail-oriented, highly organized, and passionate about quality systems, this is your chance to make a meaningful impact in the biopharma industry.
Pay $29.25/hour
What You’ll Do:
- Manage document issuance and reconciliation through electronic systems such as Veeva
- Assist with archiving and organizing physical documents in high-density storage facilities
- Support system owners to keep the site inspection ready at all times
- Update and manage Record Inventory using PRIMS for archived documents
- Help organize paper batch records from SAP for issuance and review
- Ensure documentation complies with Good Documentation Practices (GDP)
- Guide team members on quality system procedures and documentation requests
- Escalate issues proactively to maintain seamless operations
Required Skills & Qualifications:
- GMP and GDP experience in a biotech, pharma, or medical device setting
- Proven experience with document management systems, preferably Veeva
- Strong archiving, organizing, and data entry skills
- Excellent written and verbal communication abilities
- Exceptional attention to detail and organizational skills
- Ability to escalate issues promptly and collaborate effectively
Nice to Have:
- SAP/ERP experience
- Experience with electronic document management systems beyond Veeva
- Familiarity with quality systems documentation standards
Preferred Education and Experience:
- Bachelor’s degree preferred; alternatively, an Associate degree or high school diploma with 2+ years of GMP-related biopharma experience
Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer.
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