Document Control Specialist

Swiss American CDMO • Carrollton, TX

23h • 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 Change Management and Quality Records. This Document Control Specialist will ensure his/her activities maintain compliance with FDA, international/global regulations, and the ISO 13485:2016 standard as related to document control, change management, training and batch record review/disposition activities.

Requirements

• Bachelor's degree in Science, Engineering, or a related field preferred.
• Minimum of 3 years of experience in a regulated manufacturing environment (e.g., pharmaceutical, medical device).
• Experience in Document Control, Batch Record Review, or a relevant Quality/Compliance function is essential.
• Excellent written and verbal communication skills.
• Ability to read, analyze, and interpret technical documents (e.g., SOPs, protocols, reports, regulations).
• An ability to effectively communicate with internal and external stakeholders (e.g., clients, auditors).
• Ability to work with mathematical concepts such as probability, frequency, and basic statistical sampling.
• Strong analytical and data analysis skills.
• Strong analytical and problem-solving skills with a focus on risk assessment and compliance.
• Ability to apply critical thinking and sound judgment in decision-making.
• Ability to identify and resolve document-related issues effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with Adobe Acrobat and QMS software.
• Ability to efficiently generate certificates, quality records, and electronic reports.
• Must be able to lift up to 25 lbs.
• Bending, reaching and climbing stairs and short ladders or step stools.

Responsibilities

• Ensure that QA functions are compliant with all required GMP regulations.
• Assist in the conduct of internal and external audits as necessary.
• Scan and file all training records, change management records and batch records as required.
• Assist the Document Control and Quality management with the biannual review of SOPs, uniPoint reconciliation/verification, vendor change control and customer changes as required.
• Assist Document Control management with the monitoring and maintaining of the site document control system including creation, revision, and approval SOPs as required as well as monitoring of metrics, performance indicators related to change management.
• Maintain and improve the level of GMP compliance and stay abreast of industry and regulatory compliance trends and requirements.
• Ensure that all operations are performed in accordance with SOP’s, FDA and GMP guidelines.
• Receive and analyze appropriate test results for the release of final product materials.
• Review and audit completed batch records, change controls, change requests, DCN records, SOP binders to verify compliance to governing procedures and regulations.
• Scan completed batch records into Laserfiche.
• Upload records into uniPoint.
• Complete tasks in uniPoint.
• Follow up with personnel on CAPA and NCR reports as well as any change related to deliverable, training records, uniPoint or Laserfiche tasks.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level