Document Control Specialist
26 Technology Drive Irvine, CA 92618 US
Document Control Specialist is responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with Company Procedures and FDA regulations.
- Quality Systems: Maintain and improve company quality systems in compliance with FDA, International Standards (ISO), Canadian, and other regulatory agencies. This function is responsible for supporting company quality compliance and to provide control of processes, materials, and product in compliance with the Company Quality System.
- Document Control:
- Works in Document Control for managing documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.
- Comply with quality record retention, safeguard information, and retrieve the quality records more effectively.
- Executes routine DCO change packages (e.g. process redlines, proofread, make corrections, and document training). Assign part and document numbers.
- Provides guidance to other departments during the document change process.
- Maintains control of electronic and hard copy for SOPs, product drawings, labeling, artwork, process validation, manufacturing procedures, design control, marketing and educational material and test reports.
- Informs Vendors and Staff of document updates and provide controlled copies when applicable.
- Uses GDP (Good Documentation Practices) to correct records or assist others in correcting records.
- File, store, manage and track company documents for the Quality Management System.
- Performs scanning, filing, copying to maintain documents and obsolete inactive or older revision documents.
- Helps product development team maintain drawings, work orders, DCOs, etc.
- Perform administrative tasks as required.
- Releases DCOs, updates logs and lists.
- Reviews documentation for completeness
- Files, organizes, archives, releases documentation both as hardcopy and electronic files
- Consult with engineering, operations and other cross functional team for documentation requirements
- Verifies completeness of the DCO requirements prior to release of documents into QMS
- Product Development: Support product development team representing the Quality function. Support the design control aspects of product quality, program management, and quality planning from product design through manufacturing.
- Production: May implement quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for equipment and fixture records.
- Auditing: Supports internal and external audits by fulfilling document and record requests.
- Documentation: Create, review, and approve controlled documents on an electronic document control system (e.g. Quality Manual, work instructions, quality specifications, engineering specifications, lot history and device master records, procedures and validation protocols and reports).
- Training: Coordinates and/or provides training to staff in GMP/ISO, Quality Systems, and Safety awareness. Provides ongoing development and maintenance of training materials and records.
- Compliance Documentation: Ensures compliance with company quality policies and practices by assisting in "troubleshooting" problems related to the manufacture, test, and validation documentation. Support MRB, corrective action, process control, complaints, document control, calibration & preventive maintenance programs and product/process/equipment documentation activities.
- Regulatory: Facilitate compliance with management strategy and regulatory agencies such as with regulatory submission compilation and DCO release.
- Logs & Recordkeeping: Ensure compliance of quality related logs and records, including but not limited to CAPA, NCMR, ASL/APSL, equipment CAL/PM, memos, and Training.
- Safety: Implement and maintain required safety documentation for flammable, hazardous and bio-hazardous material handling, storage and disposal in compliance with City, County, State, Fire Marshall and Federal safety regulations.
- BS/AS in Engineering or scientific Discipline or equivalent document control experience is required
- 5 Years experience in a Quality role in Medical Device or other regulated industry
- Extensive experience and knowledge of regulatory requirements such as GMP's, ISO, etc.
- Strong understanding of medical device manufacturing processes, receiving inspection, in-process and finished device inspections, non-conforming material resolution, CAPA, and record keeping.
- Understanding of internal and supplier auditing, process validation, metrology, and inspection equipment documentation.
- Experience in Document Control.
- Detail oriented required.
- Able to work in a fast-paced environment.
- Strong in Microsoft Word, Excel, Power Point, Visio.
- Documentation Maintenance of hardcopy and electronic files.
- Excellent communication skills (both written and verbal) required.
- Ability to work independently or in team setting required.
Meet Your Recruiter
As Branch Manager, Alexis Cabero focuses on identifying talent for a variety of industries including medical devices, administrative support, customer service, engineering, and human resources. Graduating from The University of California, Irvine with a B.A. in Arts and Digital Media, Alexis’ recruiting career began in 2014 while staffing for assisted living facilities, where she matched passionate healthcare professionals to provide personal non-medical care for home care clients. Alexis is passionate about helping others recognize their potential, and does so by using a thorough discovery process with her candidates to better understand what areas they excel in and providing opportunities exclusive to Marquee Staffing.
While out of office, Alexis enjoys spending her free time with family and her five dogs.