Quality Document Control Specialist

InServ • Fuquay-Varina, NC

1d • Onsite

About The Position

InServ is seeking a Document Control Specialist to join our Quality team in our office in Fuquay-Varina, NC. This role 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).

Requirements

• High school diploma or equivalent
• 3 years’ minimum experience in Document Control
• Significant data-entry skills
• Excellent oral and written communication skills
• Organizational & planning skills
• Ability to identify, troubleshoot and resolve issues before major difficulties develop
• Validation and auditing skills
• MS Office skills
• Ability/desire to learn new software
• Ability to develop thorough knowledge of company QA/QC policies, procedures, and standards related to Document Control.

Nice To Haves

• Some advanced education is desired
• cGMP Biopharmaceutical experience is highly desired

Responsibilities

• Maintaining cGMP-related documents, including Standard Operating Procedures, Isometrics drawings (ISOs) with weld logs, validation/commissioning protocols, and Quality reports.
• Evaluating documents to ensure conformance and compliance with contractual specifications, government regulations, and InServ’s QA/QC policies and procedures.
• Regularly auditing and reviewing documents for compliance with procedures, cGMP, and Good Documentation Practice (GDP).
• Maintaining a robust revision control system, ensuring only current revisions are in use and obsolete versions are properly archived.
• Assisting QA/QC Personnel in training employees on GDP and cGMP documentation requirements and processes.
• Communicating process changes to ensure all team members are informed and trained in the latest practices.
• Disseminating current written policies and procedures related to compliance activities.
• Collaborating closely with various other departments to facilitate the flow of information and ensure alignment and access to required information.
• Entering and maintaining data in the document management system, including tracking document statuses, approvals, and revisions.
• Ensuring that the retrieval of necessary documents is explained and they are easily retrievable.
• Ensuring compliance with requirements regarding the retention of cGMP documents and ensuring the secure storage and disposal of documents that are no longer needed.
• Seeking opportunities to enhance cGMP documentation processes.
• Staying updated on industry’s best practices and emerging technologies that can improve efficiency and compliance in document management.
• Assisting with training subcontractors on quality requirements and compliance, as necessary.
• Performing additional Document Control activities per supervisor’s direction.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED