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Documentation Control Specialist

$23 - $25 per hour

Actalent

We are looking to hire a Documentation Control Specialist immediately. The candidate will be responsible for running the Quality Document Management System (QCBD). This includes processing Engineering Change Orders for Manufacturing Specifications and Standard Operating Procedures, Corrective & Preventive Actions, Nonconformances & OOS and Quality & Regulatory Reports. This person will support the Quality department during customer and regulatory audits and work on special projects as assigned. This position provides a foundation for further development in Quality Management or Regulatory Affairs. Responsibilities Maintain the electronic document control system, including all its modules. Create Engineering Change orders for Manufacturing Specifications and Standard Operating Procedures (SOPs) and route for approval. Monitor Manufacturing and Test Equipment calibration status. Maintain the Employee Training Requirements & Records. Review current Quality Standards and Regulations, such as ISO 13485:2016 and incorporate any new requirements into the QMS documents. Revise and update SOPs and other Quality Documents as necessary to assure accuracy and relevance or because of audits or failure investigations. Assist the Quality Manager in handling customer and regulatory audits. Assist the Quality Manager in failure investigations (Nonconformances, OOS, Complaints). Assist the Quality Manager with regulatory inquiries and certifications. Qualifications – Required Bachelor’s degree in a scientific discipline or equivalent practical experience. Solid understanding of GMP/ISO/USP requirements and data integrity principles. Prior successful work experience, preferably in a professional or technical environment. Excellent writing and verbal communication skills. Qualifications – Preferred Background in contract manufacturing or fast‑paced production environments. Skills Document control Quality assurance GMP QMS ISO 13485 Nonconformants Job Type & Location This is a contract position based out of Dallas, TX. Pay and Benefits The pay range for this position is $23.00 – $25.00 per hour. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include: Medical, dental & vision; Critical illness, accident, and hospital; 401(k) Retirement Plan – pre‑tax and Roth post‑tax contributions available; Life Insurance (voluntary life & AD&D for the employee and dependents); Short and long‑term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, vacation or sick leave). Workplace Type This is a fully onsite position in Dallas, TX. Application Deadline This position is anticipated to close on Jul 26, 2026. Equal Opportunity Employer Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Reasonable Accommodation If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr

Vacancy posted 8 hours ago
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