Documentation Specialist 2

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

Job Title: Documentation Specialist
Location: Melrose Park, IL
Duration: 3+ Months
Employment Type: Contract
Pay Range: $22 - $24.50/hour on w2

Position Summary

We are seeking a detail-oriented Documentation Specialist to support quality assurance and manufacturing operations within a regulated manufacturing environment. The individual will be responsible for preparing, reviewing, coordinating, and maintaining accurate manufacturing documentation to ensure production requirements are met and documentation complies with established quality standards and procedures.

Key Responsibilities

• Coordinate scheduled production batches to ensure the availability of complete and accurate manufacturing documentation.
• Prioritize the preparation and issuance of required documents for scheduled products.
• Calculate and assign product expiration dates while verifying critical information, including product identification numbers and product strength.
• Identify, investigate, and resolve manufacturing documentation discrepancies.
• Communicate documentation issues and corrective actions to management and relevant quality assurance team members.
• Manage documentation-related projects and support quality management initiatives.
• Develop and revise batch records to meet documentation requirements for validation protocols, special studies, and component qualifications.
• 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.

Required Qualifications

• Previous experience in quality assurance documentation, manufacturing documentation, or document control.
• Experience working with batch records and manufacturing documentation.
• Familiarity with GMP/cGMP requirements and regulated manufacturing environments.
• Strong attention to detail and ability to identify and resolve documentation discrepancies.
• Excellent organizational, communication, and coordination skills.
• Ability to manage multiple priorities and meet production-related deadlines.
• Proficiency in MS Office applications.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, or life sciences manufacturing.
• Experience preparing, reviewing, and issuing Batch Manufacturing Records (BMR) or Batch Production Records (BPR).
• Familiarity with validation documentation, production scheduling, and quality assurance processes.
• Experience calculating or verifying product expiration dates and product information.

Opportunity Overview

This contract opportunity offers the chance to contribute to manufacturing and quality assurance operations by ensuring accurate, complete, and timely production documentation.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.