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:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using DOT Compliance software systems.
• 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.
• Manage and maintain document archive process.
• Maintain original and working copy binders to ensure they contain the latest effective revisions.
• Maintain LIVE DOCs to ensure they contain the latest effective revisions.
• Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date.
• Perform daily and quarterly audits to ensure the correct version of effective documents is in binders and used in preparing batch records.
• Assist with the preparation and verifying of batch records as demanded by the Production/Packaging Schedule:
• Review production schedule to determine what needs to be performed.
• Perform batch record generation for Nephron and 503B: range 3 - 10 per day depending on type.
• Average time frame per 503B batch record: Paper MBR: 45 mins – 1 hr.; EBR: 20-30 mins.
• Average time frame per Nephron MBR; Filling: 1.5 – 2.0 hrs.; Secondary Packaging: 45 mins. – 1 hr.)
• Create batch IDs using LabVantage.
• Email and DOT system Activities
• Promptly respond to 8 – 20 request per day for emails and DOT Compliance.
• Promptly respond to email request including but not limited to: Logbook issuance and return process, Regulatory request, audit request, re-issuance, permissions, etc.
• 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.