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Description
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.
Requirements
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.