Quality Document Control Specialist

Job description:

Company Overview:

Founded in 1992, InServ is a full-service industrial contractor working in the life science, advanced manufacturing, and food and beverage industries. We specialize in four trades (mechanical, hygienic piping, HVAC, and electrical, instrumentation and controls), working from multiple locations across North Carolina and for clients across the Southeast. InServ is both a knowledgeable and reliable partner for our clients. We assist with design, adhere to schedules, and execute with the highest quality to provide a total solution.

Job Overview

Ensures that all documentation related to quality processes adheres to Standard Operating Procedures (SOPs), contract specifications, current Good Manufacturing Practices (cGMP), and regulatory standards set forth by authorities such as the Food and Drug Administration (FDA).

Responsibilities

• cGMP Documentation Management: The Document Control Specialist is responsible for maintaining cGMP-related documents, including Standard Operating Procedures, Isometrics drawings (ISOs) with weld logs, validation/commissioning protocols, and Quality reports.
• Conformance and Compliance: Evaluate to ensure conformance and compliance with contractual specifications, government regulations, and InServ’s QA/QC policies and procedures. The Document Control Specialist regularly audits and reviews documents for compliance with procedures, cGMP, and Good Documentation Practice (GDP).
• Revision Control and Tracking: Maintaining a robust revision control system is essential. The Document Control Specialist ensures that only the most current revisions of documents are in use, while obsolete versions are properly archived. This is critical to ensure that outdated documents are not being used.
• Training and Dissemination: The Document Control Specialist assists QA/QC Personnel in training employees on GDP and cGMP documentation requirements and processes. Communicates process changes to ensure that all team members are informed and trained in the latest practices. Disseminate current written policies and procedures related to compliance activities.
• Collaboration with Cross-Functional Teams: Collaborate closely with various other departments to facilitate the flow of information and ensure that all team members are aligned and have necessary access to the required information.
• Data Entry and System Maintenance: The Document Control Specialist enters and maintains data in the document management system. This includes tracking document statuses, approvals, and revisions. They ensure that the retrieval of necessary documents is explained and are easily retrievable.
• Record retention and Disposal: The Document Control Specialist ensures compliance with the requirements regarding the retention of cGMP documents and ensures the secure storage and disposal of documents that are no longer needed.
• Continuous Improvement Initiatives: The Document Control Specialist seeks opportunities to enhance cGMP documentation processes. They stay updated on industry’s best practices and emerging technologies that can improve efficiency and compliance in document management.
• Assist with training subcontractors on quality requirements and compliance, as necessary.
• Perform additional Document Control activities per supervisor’s direction.

Qualifications

• High school diploma or equivalent; some advanced education is desired.
• Self-motivated with a desire to be among a strong supportive team.
• 3 years’ minimum experience in Document Control. cGMP Biopharmaceutical experience is highly desired.
• Ability to develop thorough knowledge of company QA/QC policies, procedures, and standards related to Document Control.
• Significant data-entry skills are required.
• Must have excellent oral and written communication skills, as well as organizational & planning skills.
• Ability to identify, troubleshoot and resolve issues before major difficulties develop.
• Validation and auditing skills are required.
• MS Office skills are a must and the ability/desire to learn new software.
• Employment is contingent upon satisfying all jobsite-specific access requirements, with no outstanding restrictions from any jobsite or from working with any of InServ’s partnering General Contractors, Owners, Customers, etc

Travel Requirements: Local daily travel to assigned project or InServ’s offices.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

People with a criminal record are encouraged to apply

Work Location: In person