QA Document Control Specialist (GMP/ISO)

Swiss American CDMO, LLC.; Carrollton (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

Paycom - ATS in Carrollton, TX seeks a Document Control Specialist to ensure QA documentation compliance for Cosmetic, Drug and Medical Device processes. You will manage batch records, release activities, and maintain Laserfiche/uniPoint documentation.

Responsibilities include audits support, CAPA tracking, SOP reviews, and ERP/MRP data tasks while upholding GMP/GDP standards. Requires high school diploma with 2+ years FDA/ISO regulated experience; a BS in science/engineering is preferred.

Qualifications

• High School/GED and a minimum of 2 years in an FDA/ISO regulated manufacturing environment.
• Experience in Document Control, Batch Record Review, or Quality/Compliance.
• Strong understanding of SOPs, Validation Protocols, and Regulatory documentation.
• Excellent organizational and multitasking abilities.
• Experience with QMS & ERP/MRP software.

Responsibilities

• Perform review of batch record documentation and enter entries in ERP/MRP system; perform release activities.
• Receive and analyze test results for final product material release.
• Scan batch records into Laserfiche and upload into uniPoint.
• Ensure QA functions comply with GMP regulations.
• Create and update Product Master Files as needed.
• Review data for raw materials, intermediates and finished goods in QMS/ERP systems.
• Assist internal/external audits as needed.
• Support CAPA management, tracking, trending, and closure.
• Assist with biannual SOP reviews and uniPoint reconciliation.
• Ensure documentation activities follow SOPs, FDA and GDP guidelines.
• Support QA Engineer with QMS/ERP tasks and data entry by engineers.
• Cross-train with QA team to support delivery.

Skills

Document control

Batch record review

Quality/compliance

SOPs & validation protocols

Microsoft Office

Adobe Acrobat

QMS/ERP/MRP software

Organizational skills

Written and verbal communication

Education

Bachelor’s degree in science, engineering, or related field

Tools

QMS software

ERP/MRP software

Laserfiche

uniPoint

Job description

Paycom - ATS in Carrollton, TX seeks a Document Control Specialist to ensure QA documentation compliance for Cosmetic, Drug and Medical Device processes. You will manage batch records, release activities, and maintain Laserfiche/uniPoint documentation.

Responsibilities include audits support, CAPA tracking, SOP reviews, and ERP/MRP data tasks while upholding GMP/GDP standards. Requires high school diploma with 2+ years FDA/ISO regulated experience; a BS in science/engineering is preferred.