Document Control Specialist

Prismatik; Irvine (CA); On-site; USD 31,684 - 34,440; Full time

Job summary

Prismatik in Irvine, CA is seeking a Documentation Control Specialist to maintain engineering and product development records and oversee quality documentation.

The role requires two years in dental/medical device industry, strong MS Office skills, and GMP knowledge; pays $23.00–$25.00/hr on site with no remote options.

Qualifications

• Two years in dental or medical device industry.
• Proficient in MS Office; advanced Excel.
• Knowledge of GDPs and GMP requirements.

Responsibilities

• Maintain engineering and product development records for integrity and accessibility.
• Process and control storage of quality records.
• Interact with users to ensure conformance to QC requirements.
• Manage review and approval workflows in the electronic document management system.
• Ensure documents comply with Good Documentation Practices (GDPs).
• Assist FDA inspections and Notified Body audits as requested.
• Support internal customers with documentation needs.
• Route and release documentation.

Skills

MS Office Suite

Excel

Customer service

Document control

Quality systems

GMP knowledge

Education

High school diploma or equivalent

Job description

Essential Functions

• Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
• Processes and controls storage of Quality Records.
• Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
• Processes review and approval workflows in electronic document management system.
• Reviews document format to ensure compliance to Good Documentation Practices (GDPs).
• Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.
• Tracks and facilitates timely documentation review and implementation.
• Distributes documents in accordance to control procedures.
• Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
• Analyzes change requests for completeness.
• Provides support to internal customers with documentation needs.
• Updates electronic document profiles to reflect appropriate changes.
• Provides clerical and administrative support related to documentation processes and systems.
• Creates and maintains document templates by coding fields and uploading into the electronic document management system.
• Routes and releases documentation.
• Follows up on training requirements to ensure compliance to the department’s standard operating procedures.
• Assists with monitoring the Document Control email inbox to ensure all requests are assigned and responded to in a timely manner. Communicates among the Document Control team to ensure request are fully completed.
• Maintains the document archival room; ensures files are accurate and easily retrievable.
• Assists with training program by filing training records and logging training.
• Works with a variety of internal teams to ensure receipt of training materials.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications

• High school diploma or equivalent.
• Minimum two (2) years of experience in dental or medical device industry.
• Minimum one (1) year of customer service experience.
• Proficient skills in the MS Office Suite (Word, PowerPoint, and Outlook); advanced proficiency in Excel.
• Demonstrated knowledge of document control fundamentals, quality systems, and Good Manufacturing Practice (GMP) requirements.
• Demonstrated understanding of current medical device industry and applicable regulations.

Pay range: $23.00 to $25.00/hr. Exact compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.