Description

Job Purpose

The Document Control Manager is responsible for the day-to-day administration and execution of document control operations across the organization. This role ensures that all controlled documentation is accurate, current, compliant, and accessible to relevant stakeholders. The Manager supports adherence to regulatory and quality standards, including cGMP and FDA requirements, and provides direct oversight of the Document Control team.

Essential Duties and Responsibilities

✓Document Control & Compliance
✓Oversee electronic and paper-based document control workflows, ensuring appropriate review, approval, issuance, revision, distribution, retrieval, archival, and disposition.
✓Ensure controlled documents and electronic records maintain appropriate version control, metadata, audit trails, access controls, and retention requirements.
✓Ensure applicable electronic records and electronic signatures are managed in accordance with company procedures and applicable regulatory requirements, including 21 CFR Part 11, where applicable.
✓Promote and maintain ALCOA+ data integrity principles throughout document and records-management activities.
✓Monitor document-control metrics, identify process gaps, and implement continuous-improvement initiatives.
✓Manage the receipt, storage, retrieval, use, retention, and disposition of records in accordance with company policies.
✓Maintain Quality Assurance documentation, including training records, change controls, batch records, and related controlled documents.
✓Support the generation and issuance of batch records, logbooks, and laboratory notebooks.
✓Maintain master document lists, Process/Product Development (PD) numbers, and controlled document systems.
✓Coordinate archival and retention activities for PD studies, document revisions, logbooks, and laboratory notebooks in accordance with company procedures.
✓Lead daily document control operations and provide guidance to the Document Control team.
✓Batch Records, Product Development & Media Fill Oversight
✓Coordinate the end-to-end lifecycle of batch records, including drafting/support, review, approval, issuance, reconciliation, revision, and archival.
✓Collaborate with Process/Product Development, Manufacturing, and Quality teams to ensure accuracy and completeness of development batch documentation.
✓Assist in the preparation and revision of batch records for media fill and validation activities.
✓Manage documentation for media fill (aseptic process simulation) activities, including protocol approval, execution records, and final reports.
✓Control revisions of batch records and media fill documents to ensure proper versioning and change control compliance.
✓Attend production planning and scheduling meetings to align document control activities with manufacturing needs; coordinate the timely generation and issuance of batch records to support operations and meet established timelines.
✓Support document readiness for product development, validation, engineering, clinical, and commercial manufacturing activities, as applicable.
✓Quality & Audit Support
✓Maintain Document Control inspection readiness and ensure records can be retrieved accurately and within established timelines.
✓Support responses to audit and inspection observations related to document control, records management, and documentation practices.
✓Partner with Quality Assurance to investigate and resolve document-control discrepancies, overdue records, and procedural compliance issues.
✓Support CAPA, deviation, change control, and other quality-system activities when document-control expertise is required.
✓Leadership & Team Development
✓Provide day-to-day supervision, training, and technical guidance to Document Control staff on standards, systems, and procedures.
✓Support performance management activities, including employee development plans, 90-day reviews, and annual evaluations.
✓Foster a collaborative, accountable, and quality-focused team environment.
✓Escalate risks, concerns, and issues to senior leadership as appropriate.

Supplemental Functions

✓Maintain high-level of confidentiality, in regards to Nephron and employee information.

· Assist and participate in customer and regulatory audits and inspections as needed.

Knowledge & Skills

✓Working knowledge of Quality Assurance principles, including cGMP, FDA regulations, and data integrity requirements.
✓Understanding of document control processes, document lifecycle management, and records retention practices.
✓Familiarity with batch record lifecycle management and product development (PD) documentation requirements.
✓Proficiency in Document Management Systems (e.g., TrackWise, TrackWise Digital, Dot Compliance, Electronic Batch Records).
✓Strong technical writing, document review, and editing skills with a focus on accuracy, clarity, and compliance.
✓Solid analytical and problem-solving abilities.
✓Strong organizational skills with the ability to manage multiple tasks and deadlines simultaneously.
✓High attention to detail and ability to ensure accuracy and consistency across documentation.
✓Effective communication and interpersonal skills, with the ability to collaborate across cross-functional teams.
✓Demonstrated ability to lead, mentor, and guide team members.
✓Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint) and Adobe Acrobat.
✓Ability to work independently, demonstrate reliability, and maintain productivity under pressure.

Education/Experience

✓Bachelor's degree in Business Administration, Life Sciences, or a related field preferred.
✓Minimum 3–5 years of experience in document control and/or Quality Assurance within a regulated environment (pharmaceutical, biotechnology, or related industry).
✓Working knowledge of cGMP, FDA regulations, and data integrity principles.
✓Minimum 2–3 years of hands-on experience with Document Management Systems (e.g., TrackWise, TrackWise Digital, Dot Compliance, Electronic Batch Records).
✓Experience with batch record lifecycle management, including generation, issuance, reconciliation, and archival.
✓Exposure to Process Development (PD) documentation and media fill documentation preferred.
✓2-3 years of supervisory or team lead experience preferred.
✓Experience supporting regulatory inspections and audits (e.g., FDA) is preferred.

Working Conditions / Physical Requirements

✓This position requires frequent standing, sitting, walking, typing, and occasional bending and lifting of up to 40 lbs. throughout the facility.
✓Ability to adapt to changing priorities and shift focus to meet evolving organizational and business needs.
✓May be required to wear appropriate personal protective equipment (PPE) in designated areas.
✓Standard work schedule is Monday through Friday, 8-hour shifts; additional hours may be required based on business demands.