Documentation Specialist 2

Dexian; Illinois; On-site; USD 30,000 - 34,000; Full time

Job summary

Dexian is seeking a detail-oriented Documentation Specialist to support quality assurance and manufacturing operations in a regulated environment. You will prepare, review, coordinate, and maintain manufacturing documentation to ensure production requirements are met and compliant with quality standards.

In this contract role in Melrose Park, IL, you will manage batch records, schedule document issuance, resolve documentation discrepancies, and collaborate with QA to ensure timely, accurate

Qualifications

• Must have experience with quality assurance documentation, manufacturing documentation, or document control.
• Experience working with batch records and manufacturing documentation.
• Familiarity with GMP/cGMP requirements and regulated environments.

Responsibilities

• Coordinate production batches to ensure complete and accurate documentation is available.
• Prioritize issuance of documents for scheduled products.
• Calculate and verify expiration dates and product IDs.
• Identify and resolve documentation discrepancies.
• Communicate issues and corrective actions to QA and management.
• Manage documentation projects and support quality initiatives.
• Develop and revise batch records for validation protocols and studies.
• Participate in daily/weekly production scheduling meetings for timely documentation.

Skills

QA docs

Manufacturing docs

GMP knowledge

Attention to detail

Multitasking

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 stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.
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.