Quality Assurance Document Control Specialist

We are seeking a Document Control Specialist to support the design, implementation, and maintenance of our Quality Assurance documentation system. This role manages the issuance, tracking, and control of GMP documents including SOPs, batch records, protocols, and reports, while administering quality documentation software. The ideal candidate will help ensure a compliant and well-maintained Quality Management System.

Core Responsibilities:                                                                                                                   

• Updating, maintaining and refining document control procedures and training other staff members on document control procedures
• Filing, tracking and archiving GMP documentation.
• Establishing and maintaining records management system including secure storage, retrieval, retention and destruction.
• Participating in and supporting quality audits (internal and external), troubleshooting efforts, and other Quality System.
• Collaborating with other members of the Quality group, in support of the development and revision of procedural documents.
• Writing and maintaining document control procedures and participating in the development/improvement and roll-out of document control tools.
• Assisting in review of cGMP-controlled documents as necessary.
• Overseeing the quality review and consistency checks applied across the department, ensuring accuracy and clarity of content within and across documents.
• Ensuring global coverage for responding to urgent requests in a timely manner.
• Managing and executing the routing, review, approval, distribution and archival of new and revised controlled documents.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Qualifications: 

Required

• High school diploma or general education diploma (GED).
• 3+ years’ experience in a GMP/Regulated environment.
• Knowledge of Quality Management System and Quality Events Management Systems.
• Knowledge of Good Documentation Practices, Documentation controls and metrics analysis.
• Proficient in Microsoft Office Suite· Good written and verbal, concise and effective communication skill.
• Excellent organizational skills and ability to interact with cross functional team throughout the organization.
• Attention to detail.

Our Commitment:

• Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
• Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.