Job Purpose: 

· 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. 

Essential Duties and Responsibilities:

o Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using DOT Compliance software systems.

o Assist with document accuracy including, but not limited to: formatting headers and footers, spelling corrections, appropriate grammar and punctuation, consistent fonts and numbering sequences, etc. 

o Manage and maintain document archive process. 

o Maintain original and working copy binders to ensure they contain the latest effective revisions.

o Maintain LIVE DOCs to ensure they contain the latest effective revisions. 

o Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date. 

o Perform daily and quarterly audits to ensure the correct version of effective documents is in binders and used in preparing batch records. 

o Assist with the preparation and verifying of batch records as demanded by the Production/Packaging Schedule:

o Review production schedule to determine what needs to be performed.

o Perform batch record generation for Nephron and 503B.

o Create batch IDs using LabVantage.

o Email and DOT system Activities 

o Promptly respond to 8 – 20 request per day for emails and DOT Compliance.

o Promptly respond to email request including but not limited to: Logbook issuance and return process, Regulatory request, audit request, re-issuance, permissions, etc. 

o Promptly respond to DOT Compliance request: Obsolete, grant permissions, implementation, etc. 

Supplemental Functions: 

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

Knowledge & Skills: 

• 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.

Education/Experience: 

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

Working Conditions / Physical Requirements:

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