You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
The Document Control Specialist will be responsible for the management, organization, and tracking of all documents to ensure compliance with industry standards and internal policies. This role involves coordinating document creation, revision, distribution, and archiving, as well as maintaining accurate records in our electronic Quality Management System (QMS).
Key Responsibilities
- Manage the document control process, including the creation, review, approval, distribution, and archiving of documents.
- Ensure that all documents comply with company policies and regulatory requirements.
- Maintain and update the document management system for easy retrieval and reference.
- Collaborate with various departments to gather and prepare documentation for projects, audits, and inspections.
- Conduct regular audits of document control processes to identify areas for improvement.
- Provide training and support to staff on document control procedures and tools.
- Assist in the development and maintenance of document control procedures and best practices.
- Generate reports on document status and compliance for management review.
- Facilitate information flow between teams and stakeholders regarding document updates and revisions.
- Create and distribute Batch Record packages via the electronic QMS according to manufacturing schedules.
- Oversee the documentation library, including issuing, receiving, and tracking validation packages, batch records, logbooks, etc.
- Adhere to Good Manufacturing Practices (GMP), procedures, and policies/procedures.
- Participate in problem-solving tasks and collaborate with various disciplines to ensure timely document creation and delivery.
- Oversee the biennial review process for controlled documents and manage records related to local and off-site document storage.
- May act as a Subject Matter Expert or cross-train other staff in the documentation control area.
Qualifications
- Associate’s degree or equivalent with 2 years of relevant experience, or High School Diploma with 4 or more years of experience in a quality or production-related role within a GMP environment.
- Proven experience in document control or records management, preferably in the pharmaceutical industry.
- Strong attention to detail and organizational skills.
- Proficiency in document management systems and Microsoft Office Suite.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a team environment.
- Strong problem-solving skills and the ability to prioritize tasks effectively.
- Proficient with word processing, spreadsheet, and database software, and standard business communication tools.
- Detail-oriented with the ability to compare details in multi-page documents while managing urgent customer needs.
- Demonstrated team participation with leadership behaviors is preferred.
Skills
- Technical skills in document management systems and Microsoft Office Suite.
- Soft skills such as communication, teamwork, and interpersonal abilities.
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
