Document Control Specialist

Description

· Ability to learn and perform Document Control functions. 

· Provide support for the Quality Management System. 

· Create and maintain standard operating procedures, change control records, and documentation in accordance with cGMP while assisting as needed in any aspect of the document control process.

· Utilization of Laboratory Information Management System (LabVantage), SharePoint, and DOT Compliance software systems. 

· Prepare and verify electronic and paper batch records.

· Requires copying, filing, and scanning. 

· Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists. 

· Assists with additional work duties or responsibilities as evident or required.

· Flexibility to work overtime and weekends, if required. 

• Copying, filing, and scanning of documents. 
• Performs other similar duties as required.

Requirements

• Technical background preferred, with knowledge of cGMP, and FDA regulations.
• Strong understanding of document control procedures, standards, and best practices
• Competent in Microsoft Word and Excel
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows
• Familiar with document management software.
• Effective time management skills including prioritizing and scheduling. 
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Familiar with relevant industry regulations and compliance standards.
• Discretion in handling sensitive and confidential information.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.

• Minimum of 1 year in the pharmaceutical industry preferred.
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.