Document Control Associate Jobs in Irvine, CA (NOW HIRING)

Position Overview

Document Control Specialist is responsible for maintaining organized and updated documents related to ISO compliance. Duties include using document management software to upload or scan paper documents, retrieving documents for authorized personnel and ensuring document storage to comply with laws and regulations.

Coordinate and/or perform the day-to-day activities of Quality Systems such as supplier qualification, deviation management, change management and document control.

Assist in assuring that TS Conductor operates in accordance with current Good Manufacturing Practices & regulations and in compliance with ISO 9001:2015 Quality standards and other ISO standards.

Essential Functions

• Managing the intake, handling, and storage of documents.
• Developing and implementing processes for document control.
• Ensuring all documentation meets formal requirements and standards.
• Reviewing and updating documents as necessary.
• Tracking and managing versions of documents.
• Retrieving files as needed by company staff.
• Securing backup and storage of documents.
• Ensuring all documentation is discoverable and accessible

• Collaborate with various departments to ensure completion of deviation investigations, CARs, change controls and NCRs
• Maintain supplier qualification program:
• Evaluation supplier self-audit questionnaire
• Assist audit team during site quality system audits
• Tracking supplier performance
• Establishment of Quality Agreements/Clauses
• Participate in internal, external, third party and regulatory audits and provide responses as needed
• Support additional project team activities and/or investigations and participate in process improvement activities and projects.

• Manage changes generated in the quality system and keep the information updated and available in the system.
• Work closely with various teams to ensure that all documents are complete, accurate and up to date.
• Review the status of external calibration equipment/tools that require calibration and coordinate their collection when required.
• Request information on monthly results from the different departments to produce the monthly metrics report.
• Keep track of the Calibration and Safety labels.
• Control the communication documents with clients and/or suppliers such as corrective actions, NCR (non-conforming material report), deviations, etc.
• Perform documentary control of Work instructions/Standard Operation Procedures related to the different areas of the company.
• Verify that the proposed changes to procedures or records comply with the quality system standard.
• Participate as a member of the internal audit team of the quality system.
• Supervise and ensure compliance with document control procedures and policies.
• Additional duties as assigned.

Incentives

Benefits offered the first of the month following 30 days of employment, include: medical, dental, life insurance, long term disability, paid time off (sick and vacation), 10 company holidays, 401(k) with company match, etc.

• Referral Rewards program

Requirements / Training and Experience

• Work experience 1 to 5 years in Quality Departments.
• Preferred Bachelor's and associate degree in Associates, Engineering, Education, Technical, Business, Management, Science, Computer Science, Manufacturing, Business/Administration
• Excellent communication skills, Attention to the details, Problem solving skills. Strong work ethic and a commitment to engineering excellence and data-driven decision making. Works well on projects on their own as well as with a team, able to clearly communicate ideas.
• Preferred licenses or certifications required by the position: ISO, FDA, SQF, PO, MO, APICS, ASQ, 9001, GMO, LEAN
• Experience working with a document control system which maintains, and processes document revision as approved by change control
• Required knowledge of various digital applications, file formats and design limitations
• Must be able to organize/prioritize existing resources and incorporate new information, as needed, to implement the most effective solutions.
• Able to apply excellent functional computer knowledge in utilizing Microsoft Windows, MAC, or other technical tools in completing assignments.
• Requires excellent communication skills with ability to state messages in a clear manner by using language that is easy for others to understand.
• Able to explain programs policies and procedures in language that is understood by others.
• Requires strong understanding of the impact of a message on the organization or customer.
• Experience in document control and internal audits.
• Proficient computer equipment and Microsoft Office tools.
• Knowledge of ISO 9001:2015.
• Strong communication and interpersonal skills.
• Ability to effectively communicate with internal leaders as well as suppliers and customers.
• Excellent attention to detail and commitment to producing high-quality work.
• Ability to work autonomously and manage several tasks at the same time.
• Ability to prioritize tasks and work effectively in a fast-paced environment.
• Must be able to successfully pass E-Verify background check.