GMP Documentation Specialist II (Contract)

Dexian; Melrose Park (IL); On-site; USD 30,000 - 34,000; Part time

Job summary

Dexian is seeking a Documentation Specialist in Melrose Park, IL on a contract basis for 3+ months. The role focuses on preparing, reviewing, coordinating, and maintaining manufacturing documentation to ensure compliance with GMP/cGMP and quality standards.

Expect responsibilities around batch records, change control, and alignment with QA and manufacturing operations. The contractor will support documentation-related projects, participate in scheduling meetings, and ensure timely issuance of

Qualifications

• Experience with QA/documentation in regulated manufacturing

Responsibilities

• Coordinate scheduled production batches to ensure complete and accurate manufacturing documentation
• Prioritize the preparation and issuance of required documents for scheduled products
• Calculate and assign product expiration dates while verifying product IDs and strength
• Identify, investigate, and resolve manufacturing documentation discrepancies
• Communicate documentation issues and corrective actions to management and QA
• Manage documentation-related projects and support quality management initiatives
• Develop and revise batch records to meet documentation requirements for validation protocols
• Participate in daily and weekly production scheduling meetings to ensure timely preparation and issuance of required documentation
• Monitor approved production schedules and respond promptly to changing manufacturing requirements
• Ensure documentation accuracy, completeness, consistency, and compliance with applicable quality procedures
• Perform additional documentation and quality support responsibilities as assigned

Skills

Document control

Quality assurance

GMP/cGMP

Attention to detail

MS Office

Communication

Tools

MS Office

Job description

Dexian is seeking a Documentation Specialist in Melrose Park, IL on a contract basis for 3+ months. The role focuses on preparing, reviewing, coordinating, and maintaining manufacturing documentation to ensure compliance with GMP/cGMP and quality standards.

Expect responsibilities around batch records, change control, and alignment with QA and manufacturing operations. The contractor will support documentation-related projects, participate in scheduling meetings, and ensure timely issuance of