Document Control Professional

Position Overview

Alliance Biotech Solutions is recruiting several Document Turnover Specialists in the Raleigh, NC area. The primary responsibility is to oversee the coordination, review, and management of GMP documentation ensuring manufacturing, laboratory, validation, and quality records are thorough, precise, and ready for Quality Assurance evaluation and final approval. This role acts as an essential connection between Manufacturing, Quality, Validation, Engineering, and Laboratory teams, guaranteeing documentation adheres to Good Documentation Practices (GDP), current GMP standards, and internal quality protocols.

Key Duties

• Examine manufacturing, laboratory, validation, and equipment documents for completeness, precision, and compliance with GDP and cGMP standards.
• Manage the turnover process of GMP documentation packages to Quality Assurance, ensuring the completeness and proper arrangement of all necessary records.
• Detect documentation flaws, missing approvals, or inconsistencies and collaborate with cross-disciplinary teams to resolve these issues swiftly.
• Maintain document status tracking and handle records within Electronic Document Management Systems (EDMS) and other quality platforms.
• Collaborate with Manufacturing, QA, QC, Validation, Engineering, and Document Control groups to facilitate efficient document flow and prompt completion of packages.
• Support commissioning, qualification, validation, batch release, and audit preparedness by ensuring documentation is finalized, accurate, and inspection-ready.
• Engage in continuous improvement efforts to elevate document quality, compliance, and process efficiency.

Experience and Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related technical area; equivalent GMP experience considered.
• One to three years’ experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or similar life sciences setting.
• Understanding of cGMP regulations, Good Documentation Practices (GDP), and ALCOA+ data integrity principles.
• Experience reviewing controlled GMP documents such as batch records, validation and laboratory documentation, or quality system records.
• Familiarity with Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), or related regulated documentation platforms.
• Strong organizational, communication, and critical thinking skills with sharp attention to detail and capability to handle multiple tasks.
• Self-driven with ability to work independently and collaboratively in a fast-paced GMP environment while meeting deadlines consistently.

Benefits and Compensation

• Competitive industry salary as a full-time employee.
• 20 days of flexible paid time off.
• Medical, dental, and vision insurance available with minimal employee expense.
• Employer-covered long-term and short-term disability insurance.
• 401(k) plan inclusive of employer contributions.

Company Information

Alliance Biotech Solutions is a leading consulting firm offering biopharmaceutical engineering and validation services, specializing in Commissioning, Qualification, and Validation (CQV). Their ethos centers on empowering employee growth and recognizing the critical role their team plays in client success.

Equal Employment Opportunity

Alliance Biotech Solutions provides equal opportunity employment without discrimination based on race, color, national origin, citizenship, military or veteran status, religion, disability, marital status, sex, sexual orientation, gender identity, age, genetic information, or any other protected attribute.

Additional Hiring Policies

The company does not accept unsolicited resumes from staffing agencies; all unsolicited resumes become company property without obligation of a placement fee. All hires must verify identity and eligibility to work in the United States and complete employment eligibility documentation upon hiring.