Regulatory QA Document Control Specialist

Swiss American CDMO, LLC.; Carrollton (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

Swiss American CDMO, LLC. is seeking a Document Control Specialist to ensure QA documentation aligns with FDA/ISO standards and GMP requirements. The role involves reviewing batch records, handling ERP/MRP entries, scanning records into Laserfiche, and maintaining Product Master Files.

You will work on-site five days a week, supporting audits, CAPA, and cross-training with QA peers to sustain compliant documentation processes across materials and finished goods.

Qualifications

• 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.

Responsibilities

• Review batch documentation and enter entries in ERP/MRP and perform release activities.
• Receive and analyze test results for final product materials release.
• Scan batch records into Laserfiche and upload records into uniPoint.
• Ensure QA functions are compliant with GMP regulations.
• Create, maintain and update Product Master Files as needed.
• Review data for Raw Materials, Intermediates and Finished goods specifications in QMS/ERP.
• Assist in internal and external audits as necessary.
• Assist CAPA management, tracking, trending, review and closure.
• Assist biannual review of SOPs, uniPoint reconciliation/verification.
• Ensure documentation activities align with SOPs, FDA and GDP guidelines.
• Support QA Engineer with QMS and ERP tasks; cross-train with QA team.

Skills

Document control

Batch record review

Quality/compliance

SOPs

Regulatory documentation

Microsoft Office

Adobe Acrobat

QMS & ERP/MRP software

FDA/ISO regulations

Education

High School/GED

Bachelor’s degree in science/engineering

Tools

Laserfiche

uniPoint

ERP/MRP software

QMS software

Job description

Swiss American CDMO, LLC. is seeking a Document Control Specialist to ensure QA documentation aligns with FDA/ISO standards and GMP requirements. The role involves reviewing batch records, handling ERP/MRP entries, scanning records into Laserfiche, and maintaining Product Master Files.

You will work on-site five days a week, supporting audits, CAPA, and cross-training with QA peers to sustain compliant documentation processes across materials and finished goods.