Document Control Specialist

Swiss American CDMO • Carrollton, TX

3d • Onsite

About The Position

Plans and conducts activities associated with the quality assurance and compliance of Cosmetic, Drug and Medical Device processes, materials, systems and products by performing duties related to initiation, approval and closure of SWISS Quality Records (i.e. “hard copies” & electronic files in the QMS and ERP/MRP systems). The Document Control Specialist will ensure that all QA documentation activities maintain compliance with FDA, international/global regulations, and the ISO 13485:2016 standard as related to document control, review and approvals.

Requirements

• High School/GED and a minimum of 2 years in an FDA/ISO regulated manufacturing environment.
• Ability to pass a basic English comprehension test (5th-grade level).
• Experience in Document Control, Batch Record Review, or Quality/Compliance.
• Strong understanding of SOPs, Validation Protocols, and Regulatory documentation.
• Highly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same time.
• Experience in Quality Operations and Technical Operations.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Experience with QMS & ERP/MRP software.

Nice To Haves

• Bachelor’s degree in science, engineering, or related field.
• Strong proficiency in sampling methods i.e. ANSI Z1.4/ISO 2859-1.
• Strong data analysis (statistical) and risk assessment skills.
• Experience communicating with auditors and clients.

Responsibilities

• Perform critical review of executed batch record documentation making the required entries in the ERP/MRP system and performing all release activities.
• Receive and analyze appropriate test results for the release of final product materials.
• Scan completed batch records into Laserfiche. Upload records into uniPoint. Complete tasks in uniPoint.
• Ensure that QA functions are compliant with all required GMP regulations.
• Creates maintains and updates the Product Master Files as needed.
• Reviews and enters data for Raw Materials, Intermediate and Finished goods specifications in the QMS and ERP/MRP Systems.
• Assist in the conduct of internal and external audits as necessary.
• Assists the CAPA management, tracking, trending, review and closure.
• Assist as needed with the biannual review of SOPs, uniPoint reconciliation/verification.
• Ensure that all documentation activities are performed in accordance with SOP’s, FDA and GDP guidelines.
• Supports QA Engineer with QMS and ERP tasks as needed and as assigned by QA management.
• Support engineers with data entry activities as needed.
• Cross-training with other QA team members in an effort to support team delivery in the event of resource.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED