Jr Documentation Specialist; Pharma, Biotech, Medical Device

Job Description

Jr Documentation Specialist - Batch records (Pharma, Biotech, Medical Device)

Irvine, CA 92618 (Local candidates only. Onsite)

$27-$32hr (Weekly pay + Benefits)

9 months contract (Excellent potential for permanent)

Full- time: M-F 7am-3:30pm

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives. This position will be responsible for supporting the manufacturing of products by creating/processing/reviewing production batch records following established GDP/GMP processes and procedures.

How You’ll Make An Impact:

• 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).

What You Bring:

• Associates degree or equivalent experience
• 1-5 years in a Regulated industry such as medical device, pharmaceutical or biotechnology
• Experience on reviewing, printing batch records and data entry/entering batch records
• Experience in Document Change Control and quality system documents
• Must have general knowledge of Good Documentation Practices (GDP).
• Experience in writing, updating and filing SOPs, NCR's and CAPAs'
• Experience to review documents for format, accuracy, and compliance
• Experience working with ERP systems such as SAP or similar ERP
• Bonus:
  Experience with Veeva (quality management system software solution)
• Good oral and written communication skills.
• Proficient in Microsoft Office suite.
• Team player, flexible, and quality minded.

Please send your resume, thank you!