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)