Job description

Document Control Specialist

The primary purpose of this position is to perform and serve as the documents and records coordinator and is focused on maintenance and processing of document workflows including document management system, batch and process documentation and document storage (physical and electronic).

You will be responsible to maintain, create, and modify the documents in a compliant and efficient manner and for training, auditing, and ensuring compliance with business processes and applications across the organization. You will develop and maintain KPI reports, identify root causes, and implement process improvements as directed by Management.

DUTIES AND RESPONSIBILITIES:

· The Document Control Specialist is responsible for scanning, indexing, linking, archiving, maintaining historical files, electronic filing and distribution of documents, SOPs, and Forms.

• Enters, updates, and edits of controlled documents and coordinates requirements for new documents.
• Assures that all completed documents have been signed-off by the appropriate personnel.
• Serves as a local system administrator for the Quality Management System.
• Write new and revised Standard Operating Procedures (SOPs), raw materials, packaging materials, product specifications, testing procedures and forms.
• Review documents for completeness and accuracy and ensures compliance with all Good Manufacturing Practice (GMP) rules, testing and safety programs.
• Collaborates with departments to ensure timely implementation of document change requests.
• Controls distribution and monitor workflow of controlled and revised documents.
• Support internal and external audits. Participate as team member for customer, regulatory and third-party audits.

• Coordinate the Disposal of Rejected Materials, Create Deviations, and review Non-Conformance Reports
• Provides guidance and advice on approved procedures, standardization and requirements associated with documents.
• Ensure controlled documents are periodically reviewed for relevance and accuracy.

• Inform Management of compliance, safety or quality issues or of any processes, repairs or adjustments which become non-compliant with specified requirements.
• Ability to identify best practices and any associated gaps and to initiate action to prevent the occurrence of nonconformities relating to safety and the quality of the product or processes.

• Issue controlled documents for training, testing or batch production purposes
• Maintain company training matrix, audit training records to ensure records are complete and accurate and filed for new and/or revised processes.

• Develop and maintain KPI reporting tools for management

• Collaborate with other departments to catalog drawings, packages and specifications.

• Review of documents created by others for accuracy, clarity, formatting, and compliance to cGMP/ISO requirements

• Provides training to new staff on document management system, processes and procedures.
• Assist with other QA functions as needed.
• Performs other duties as assigned.

REQUIREMENTS:

• Minimum of 3 years of technical writing/document control experience in the cosmetic/pharma/food industry.

· BA/BS or demonstrated equivalency of experience and/or education.

• Prior Business Process, Document Control, Quality and Records Management experience.

• Must have strong computer skills and be proficient in Microsoft Office tools such as Word, Excel; Adobe Acrobat.
• Ability to work independently and with team.
• Strong attention to detail, accuracy and multi-tasking abilities.

• Critical thinking skills and ability to retain complex work direction.
• Ability to identify opportunities for improvement and contribute ideas and skills.
• Strong organizational, time management, project management and problem-solving skills.

• Experience in a cGMP or ISO certified operation.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Glendale Heights, IL 60139: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Microsoft Office: 3 years (Preferred)

Work Location: One location

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