Document Control Specialist
Astrix Inc
Pay Rate Low: 65000 | Pay Rate High: 65000
We are hiring for a Document Control Specialist who want to continue their career in biopharmaceutical manufacturing! This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry.
Schedule: 1 st shift
Location : Chicago, Illinois
Type of Job: Temp to Hire
Responsibilities:
- Provide daily administrative support to the Manufacturing Manager, including scheduling, coordination of activities, and preparation of reports
- Facilitate communication between Manufacturing and cross-functional departments such as Quality Assurance, Quality Control, Supply Chain, and Facilities
- Draft, revise, and review controlled GMP documents including Standard Operating Procedures (SOPs), batch records, and training materials
- Ensure document accuracy, compliance, and alignment with internal quality standards and applicable regulatory requirements
- Manage document routing, approval workflows, version control, and archival within the documentation management system
Support Corrective and Preventive Action (CAPA) activities, including data collection, documentation, tracking, and follow up. - Assist with investigations by gathering relevant data, compiling summaries, and supporting root cause analysis efforts.
- Provide handson support in cleanroom operations during periods of increased demand, staffing gaps, or special projects. Cleanroom operational support may require working 1 st shift or 2 nd shift.
Requirements:
- Bachelor's degree in a scientific field
- Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance preferred
- At least 2 years of related experience in a GMP manufacturing environment, pharmaceuticals or biosimilars preferred
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! INDBH
#LI-LD1
$60k - $80k
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