Document Control Specialist II

Job Code:

Q1048

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Post Date:

November 23, 2021

JOB DESCRIPTION

The Document Control Specialist II maintains aspects of the Document Control process by processing and implementing document changes with respect to conformance to current Good Manufacturing Practices (cGMP), and approved procedures and policies. The individual will create, process, and implement change controls in an electronic system, compile and maintain controlled records and related files to release documents to manufacturing and other departments. The Document Control Specialist II will receive minimum instructions on routine tasks, and directed instructions on new assignments.

RESPONSIBILITIES

  • Process GMP documents: Employ thorough proofreading and editing skills to prevent errors and ensure documents conform to regulatory, industry, and Matica Bio's guidelines.

  • Maintain an organized system of document status via multiple interfaces including but not limited to Excel, DMS, and Outlook.

  • Prioritize workloads in order to effectively manage documents that have short turnaround times for processing and coordinate the review and revision of procedures, specifications and forms.

  • Interact on ad-hoc basis to provide support and coaching for participants in the revision process.

  • Adhere to tasks provided by other departments and from within the Documentation group with nominal supervision.

  • Promotes economy and efficiency in the creation, organization, maintenance, retention, use, and disposition of Matica’s official records.

  • Provides cGMP records management support in accordance with regulatory guidelines and company policies and procedures.

  • Coordinates simple, efficient records retrieval requests and responds in writing to requests for information.

  • Assists in records organization, packing, listing, auditing and retrieving records from third party records partners.

  • Provides support of regulatory inspections, customer and internal audits.

  • Review and maintain employee training files.

  • Create and maintain various filing systems.

  • Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends.

  • Other job functions as assigned.

QUALIFICATIONS

  • Bachelor’s degree in a life science, or an equivalent combination of education, experience and training 

  •  3 years of Document Control Experience to include 1 year of relevant quality assurance experience in a cGMP environment