Document Control Specialist

Job Description:

This position requires a thorough understanding of cGMP regulations and compendia requirements. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various departments. Must demonstrate strong interpersonal skills, must possess the ability to pay strong attention to detail, and must be able to perform with minimal supervision.

KEY RESPONSIBILITIES:

• Provide support to projects pertaining to document control management systems.
• Provide administrative support to document control related activities e.g. document filing, binding, and retrieval.
• Manage and ensure the provision of administrative support to internal / external customers to ensure that all documents are maintained in accordance to the records retention requirements
• Manage documents in Veeva QualityDocs (VQD) or equivalent electronic Document Management System according to the relevant procedures and standards.
• Draft, compile, review and update appropriate policies and procedures relevant to documentation management and archival on site to comply with the regulatory requirements.
• Maintaining electronic and hardcopy Documentation through its' lifecycle according to the QMS and GRS.
• Maintaining electronic and hardcopy versions of GxP Documentation from retention to archive
• Responsible for archiving and destruction of all Site Batch documentation in accordance with regulatory, QMS and GRS requirements
• Ensure master copies of documents are held in secure storage, archived, retrievable and reviewed/destroyed according to GRRS and company processes and policies
• Issue notification of Document changes to site (e.g. new issues, withdrawals, version updates)

Minimum Level of Education:

- Associate degree or B.S. degree
- Understands cGMP regulations.
- Follows established procedures.
- Strong QA background.
- Can look for improvements and/or provide solutions to a variety of problems of moderate scope and complexity.
- Works well with members within and outside of the group.
- Can influence the team positively by participating with others in group improvement activities.

Minimum Experience:

• Proficient knowledge of Microsoft applications
• Appreciation of the products manufactured on site so that administrative support can be achieved efficiently
• Knowledge of Microsoft Office software e.g. Word, Excel and PowerPoint
• Good communication skills
• People interaction skills
• Good Organization skills
• Experience in quality systems, including validation, documentation, and compliance department preferred
• Minimum 1 to 3 year’s industrial experience in quality organizations, either in operations or assurance functions.

Location: Rockville, MD

Duration: 1 Year (potential for extension)

Hybrid (60% remote / 40% on-site)
Shift: Standard 1st shift (flexible hours)