Document Control Specialist

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

Job Details: Job Location: Corporate - CARROLLTON, TX, Salary Range: Undisclosed, This role is on-stie 5 days a week.

Position Summary: 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.

Essential Duties and 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

Qualifications: Essential Skills and 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.

Preferred Skills and Qualifications:

• 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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift up to 25 lbs. Bending, reaching and climbing stairs and short ladders or step stools.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.