Document Control Specialist

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

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.