The Document Control Specialist II (Temporary) executes and improves document control processes within Quality Assurance. Working with increased independence, this role ensures the accurate creation, routing, formatting, issuance, implementation, and archival of controlled quality documentation in compliance with cGMP regulations and ISO standards. The position acts as a cross-functional resource, supports audit and inspection readiness, assists in training junior staff, and contributes to electronic Document Management System (eDMS) enhancements.
Responsibilities:
Document Processing & Management: Process, route, and manage controlled documents (SOPs, batch records, forms, protocols) through the electronic Document Management System (eDMS) in accordance with cGMP standards. Technical Review & Formatting: Conduct technical reviews and formatting checks on documents to align with established style guides, standard guidelines, and version control principles. Lifecycle & Periodic Reviews: Manage periodic review cycles, issue notifications, maintain master trackers, SharePoint libraries, and dashboards to track document lifecycle status. Audit & Inspection Readiness: Coordinate the retrieval, submission, and organization of records for client audits, regulatory inspections, and internal reviews. Cross-Functional Collaboration: Partner with Manufacturing, QC, QA, and other departments to streamline document issuance, change control, and archiving processes. Process Improvement & Guidance: Identify workflow gaps, suggest continuous improvements (templates, procedures), and provide technical guidance to authors and new team members. Record Retention: Manage off-site archival and record retention procedures in compliance with internal policies.
Working hours: 8:00 AM - 5:00 PM
Skills:
Education: Bachelor's degree in Life Sciences, QA/RA, or Business. Learning Management Systems: Experience or familiarity with training records, eLMS, or Learning Management Systems. Audit Experience: Direct experience participating in audit preparation or backroom documentation support activities
Education:
Associate
Experience:
1-4 years
Qualifications:
Education: Associate?s degree in Life Sciences, Quality/Regulatory Affairs, Business, or a related field (or equivalent work experience). Experience: Minimum of 2-4 years in document control or quality systems within a cGMP-regulated environment. Technical Systems: Hands-on experience using eDMS platforms (e.g., Veeva, MasterControl, or equivalent). Regulatory & Compliance Knowledge: Working knowledge of cGMP documentation practices, FDA/ICH guidelines, and version control rules. Core Competencies:High attention to detail and accuracy in document handling. Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and SharePoint. Strong organizational, time management, and troubleshooting skills for document formatting and workflows.
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
key responsibilities
Document Processing & Management: Process, route, and manage controlled documents (SOPs, batch records, forms, protocols) through the electronic Document Management System (eDMS) in accordance with cGMP standards. Technical Review & Formatting: Conduct technical reviews and formatting checks on documents to align with established style guides, standard guidelines, and version control principles. Lifecycle & Periodic Reviews: Manage periodic review cycles, issue notifications, maintain master trackers, SharePoint libraries, and dashboards to track document lifecycle status. Audit & Inspection Readiness: Coordinate the retrieval, submission, and organization of records for client audits, regulatory inspections, and internal reviews. Cross-Functional Collaboration: Partner with Manufacturing, QC, QA, and other departments to streamline document issuance, change control, and archiving processes. Process Improvement & Guidance: Identify workflow gaps, suggest continuous improvements (templates, procedures), and provide technical guidance to authors and new team members. Record Retention: Manage off-site archival and record retention procedures in compliance with internal policies.
experience 1-4 years
skills Education: Bachelor's degree in Life Sciences, QA/RA, or Business. Learning Management Systems: Experience or familiarity with training records, eLMS, or Learning Management Systems. Audit Experience: Direct experience participating in audit preparation or backroom documentation support activities
qualifications
Education: Associate?s degree in Life Sciences, Quality/Regulatory Affairs, Business, or a related field (or equivalent work experience). Experience: Minimum of 2-4 years in document control or quality systems within a cGMP-regulated environment. Technical Systems: Hands-on experience using eDMS platforms (e.g., Veeva, MasterControl, or equivalent). Regulatory & Compliance Knowledge: Working knowledge of cGMP documentation practices, FDA/ICH guidelines, and version control rules. Core Competencies:High attention to detail and accuracy in document handling. Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and SharePoint. Strong organizational, time management, and troubleshooting skills for document formatting and workflows.
education Associate