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Documentation Specialist
2 months ago
Initial 9 month contract with possible extension and/or conversion to permanent employment.
7am - 330pm onsite, Monday to Friday
This position is for an entry-level Documentation Specialist who will be responsible for supporting the manufacturing of products by creating/processing/reviewing production batch records following established GDP/GMP processes and procedures.
- Reviews documents for format, accuracy, and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
- Coordinates with team members to efficiently process Change requests according to ISO /quality/ change management standards.
- Follow procedures and work instructions to execute production tasks.
- Complete inventory and quality transaction in SAP Inventory System
- Complete required documentation in an accurate and timely manner following Good Documentation Practices (GDP).
**Qualifications**:
- Associate’s degree or equivalent (science field preferred).
- 0-2 years in a regulated industry (medical device, pharmaceutical, biotechnology preferred).
- Experience working with ERP systems such as SAP, and Product Lifecycle Management, preferred.
- May have general knowledge of Good Documentation Practices (GDP).
- Good oral and written communication skills.
- Proficient in Microsoft Office suite and Visio.
- Team player, flexible, and quality minded.
**Job Disclaimer**:
- Equal Opportunity Employer/Veterans/Disabled_
- The Company will consider qualified applicants with arrest and conviction records._
**Job Type**: Contract
Pay: $27.00 per hour
Expected hours: 40 per week
**Benefits**:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
**Education**:
- Associate (required)
**Experience**:
- Medical device/Pharmaceutical/Biotech industry: 1 year (required)
- ERP systems: 1 year (required)
- GDP: 1 year (required)
Ability to Relocate:
- Irvine, CA 92602: Relocate before starting work (required)
Work Location: In person
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