Job Description
Job Title: Document Control Specialist (Temp to Hire) Location: Garland, TX 75238 Schedule: Monday - Friday | 8:00 AM - 4:30 PM Position Overview: We are seeking a
Document Control Specialist to join our team on a
temp-to-hire basis. In this role, you will be responsible for managing and controlling the flow of documentation through the company, ensuring all documents are accurate, compliant, and easily accessible. You will oversee document creation, updates, and adherence to regulatory standards, specifically for cGMP documentation.
Key Responsibilities: Document Control & Management: - Write, update, issue, and maintain Quality Assurance (QA) documents, including SOPs, Work Instructions, Forms, Technical Files, Master Manufacturing Records (MMRs), Batch Records, Specifications, and other cGMP-related documents.
- Serve as the Document Control Software Administrator , managing content types, document control numbers, user rights, and user groups.
- Review all new and revised controlled documentation for format, content, and consistency.
- Coordinate the change control process , ensuring proper documentation and approval.
- Periodically review and update company SOPs to ensure compliance and relevance.
- Collaborate with subject matter experts (SMEs) to develop and improve SOPs.
- Assist in establishing, implementing, and maintaining the Quality Management System (QMS).
Process Improvement & Documentation Maintenance: - Identify areas for process improvements in efficiency and quality, and implement approved changes.
- Maintain and update Master Manufacturing Records (MMRs) and Master Packaging Records (MPRs) .
- Ensure documentation is compliant with internal procedures and external regulatory standards.
- Provide hard copies or scanned documents for Regulatory Audits (internal and external) as needed.
Reporting & Compliance: - Create document status reports and track document revisions.
- Assist with implementing an improved document management system.
- Ensure that all documentation aligns with regulatory and statutory standards .
Qualifications & Skills: Technical Skills: - Proficient in navigating document control software and maintaining document control numbers.
- Strong computer skills, including Microsoft Office and data entry in ERP systems .
- Knowledge of technical writing , including process writing and document design.
- Ability to understand and interpret regulatory guidelines and cGMP requirements .
Communication & Organizational Skills: - Ability to write, speak, and read in English to ensure proper documentation and communication.
- Excellent organizational skills and attention to detail.
- Strong collaboration and interpersonal skills, with the ability to work effectively with different departments.
- Good time management and initiative in driving tasks to completion.
Additional Competencies: - Written and verbal communication proficiency.
- Ability to adapt to changing processes and provide solutions.
Physical Requirements: - Lift up to 15 lbs as needed.
- Sit, stand, kneel, twist, turn, and stoop regularly.
- Use a keyboard, computer, and calculator for extended periods.
- Reach forward and overhead as needed.
- Ability to remain standing or sitting for up to 4+ hours at a time.
Education & Experience: - Bachelor's degree or a combination of 3 years of work experience in a Quality Management position.
- Familiarity with Ensure software is a plus.
Other Requirements: - Understanding and adherence to safety procedures and practices in the workplace.
Contract-to-Hire Information: This is a
temp-to-hire position, with the potential for permanent employment based on performance and business needs.
COM168 - Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Nesco Resource
Job Tags
Permanent employment, Contract work, Temporary work, Work experience placement, Monday to Friday,