Document Control Clerk

POSITION PURPOSE
 
As a Document Control Clerk at Bayport Laboratories, you will support the day-to-day management, organization, and maintenance of company documents and quality records. This position is responsible for ensuring documents are properly prepared, filed, issued, maintained, and archived in accordance with established document control procedures and applicable FDA, GMP, and internal quality standards.
 The Document Control Clerk works closely with Quality, Regulatory, Manufacturing, Operations, and other departments to maintain accurate and accessible documentation. The ideal candidate is highly organized, detail-oriented, dependable, and able to manage multiple priorities while maintaining confidentiality and accuracy.
 
ESSENTIAL FUNCTIONS AND BASIC DUTIES
 
·        Document Control: Assist with the preparation, processing, filing, issuance, revision, and archiving of controlled documents, including SOPs, work instructions, batch records, specifications, forms, and other quality documents.
·        Document Tracking: Maintain document logs, trackers, and databases to ensure documents are properly routed, reviewed, approved, issued, and archived.
·        Version Control: Verify that current and approved versions of documents are available for use and assist in removing or archiving obsolete documents in accordance with established procedures.
·        Record Management: Organize and maintain quality records and documentation to ensure records are accurate, complete, legible, traceable, and readily accessible.
·        Document Filing: Maintain electronic and hard-copy filing systems and ensure documents are filed according to established procedures and retention requirements.
·        Change Control Support: Assist with document change requests, revisions, approvals, and implementation activities. Track outstanding document changes and follow up as needed.
·        Data Entry: Enter and update document and record information accurately in electronic document management systems, spreadsheets, databases, and other company systems.
·        Audit and Inspection Support: Assist with retrieving, organizing, and preparing documents and records for internal audits, customer audits, and regulatory inspections.
·        Training Records: Assist with maintaining employee training records and documentation related to required procedures, SOPs, and other controlled documents.
·        Document Distribution: Assist with the controlled distribution of approved documents to appropriate departments and personnel.
·        Cross-Functional Communication: Communicate with Quality, Regulatory, R&D, Manufacturing, Operations, and other departments regarding document status, missing information, revisions, and record requirements.
·        System Maintenance: Assist with maintaining electronic document management systems (EDMS), ensuring documents are properly organized, accessible, and maintained according to established procedures.
·        Compliance: Follow company procedures and good documentation practices (GDP), as well as applicable FDA and GMP requirements, when handling controlled documents and quality records.
·        Confidentiality: Maintain confidentiality and security of company, employee, customer, and quality-related information.
·        Continuous Improvement: Identify opportunities to improve document organization, filing practices, tracking methods, and administrative processes.
 
 PERFORMANCE MEASUREMENTS
 
Performance will be evaluated during annual reviews based on:
 
·        Accuracy and completeness of documentation and records
·        Timeliness of document processing and filing
·        Compliance with document control procedures and applicable GMP requirements
·        Proper maintenance of document versions and records
·        Audit and inspection readiness
·        Ability to meet established deadlines and priorities
·        Organization and accessibility of records
·        Communication and responsiveness to internal departments
·        Demonstrated reliability, accountability, and attention to detail
·        Contributions to continuous improvement of document control processes
 
QUALIFICATIONS
 
·        High school diploma or equivalent required.
·        Associate degree in Arts, Science, Applied Science, Business Administration, or a related field preferred.
·        Previous experience in document control, records management, quality, administrative support, or a regulated manufacturing environment preferred.
·        Experience in cosmetics, pharmaceuticals, food, medical devices, or other regulated industries is a plus.
·        Basic understanding of GMP and good documentation practices preferred.
·        Familiarity with FDA requirements and regulated documentation practices is a plus.
·        Strong attention to detail and accuracy.
·        Strong organizational and time management skills.
·        Ability to prioritize and manage multiple tasks and deadlines.
·        Ability to follow established procedures and instructions consistently.
·        Good written and verbal communication skills.
·        Proficiency with Microsoft Office applications, including Word and Excel.
·        Ability to learn and effectively use electronic document management systems and other company software.
 
Education/Certification:
 
·        High school diploma or equivalent required.
·        Associate degree in Arts, Science, Applied Science, Business Administration, or a related field preferred.
·        Previous experience in document control, records management, quality, administrative support, or a regulated manufacturing environment preferred.
·        Experience in cosmetics, pharmaceuticals, food, medical devices, or other regulated industries is a plus.
·        Basic understanding of GMP and good documentation practices preferred.
·        Familiarity with FDA requirements and regulated documentation practices is a plus.
·        Strong attention to detail and accuracy.
·        Strong organizational and time management skills.
·        Ability to prioritize and manage multiple tasks and deadlines.
·        Ability to follow established procedures and instructions consistently.
·        Good written and verbal communication skills.
·        Proficiency with Microsoft Office applications, including Word and Excel.
·        Ability to learn and effectively use electronic document management systems and other company software.
                                    
Required Knowledge:
• Basic understanding of document control and record-keeping practices.
• Familiarity with quality systems and documentation within a manufacturing environment preferred.
• Basic knowledge of GMP and good documentation practices.
• Understanding of document versioning, filing, tracking, and retention practices.
• Ability to follow established procedures and recognize documentation discrepancies or missing information.
• Basic understanding of data integrity and controlled information.
• Demonstrates professionalism, accountability, dependability, and a collaborative work ethic.
• Commitment to personal and professional growth and continuous learning.

Experience Required:
• 1–2 years of related work experience in document control, administrative support, quality, records management, or a regulated manufacturing environment preferred.
• Experience working with controlled documents, quality records, databases, or electronic filing systems is a plus.
• Experience in a GMP-regulated environment is preferred but not required.

Skills/Abilities:
• Strong organizational and time management skills.
• Excellent attention to detail and accuracy.
• Strong filing, documentation, and record-keeping skills.
• Ability to accurately enter and maintain information in electronic systems and spreadsheets.
• Ability to manage multiple tasks and meet established deadlines.
• Ability to maintain confidential and controlled information.
• Strong follow-through and ability to track outstanding items.
• Ability to identify errors, inconsistencies, or missing information.
• Good written and verbal communication skills.
• Ability to work independently with appropriate direction and as part of a cross-functional team.
• Proficiency with Microsoft Word, Excel, Outlook, and other standard office applications.
• Ability to adapt to changing priorities and work effectively in a fast-paced manufacturing environment.