Job Details

ID #40926565
State North Carolina
City Raleigh / durham / CH
Job type Contract
Salary USD competitive competitive
Source Real Staffing
Showed 2022-05-15
Date 2022-05-15
Deadline 2022-07-14
Category Software/QA/DBA/etc
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Doc Control Specialist

North Carolina, Raleigh / durham / CH, 27601 Raleigh / durham / CH USA

Vacancy expired!

Raleigh, NC

Documentation Specialist

Onsite

The Documentation Specialist is responsible for maintaining plant-wide control of GMP documents, and is the subject matter expert for creation, accessibility, and archiving of documents including SOPs, batch records, and logbooks.

Key Responsibilities

Position will be responsible for the following:
  • Assures that GMP documentation is created, reviewed, approved, filed or made available in the controlled document management system in accordance with company and regulatory policies.
  • Oversees the process of generating, approving, numbering, changing, distributing, tracking, storing, and archiving GMP documents.
  • Ensures the integrity of the system or systems tracking the organization and location of GMP documents.
  • Liaises with all functional groups within the facility to assist in the creation, tracking and control of documents to ensure consistency within the controlled document management system.
  • Approves departmental SOPs.
  • Qualified trainer for document control systems.
  • Serves as a local super-user or administrator for document control systems.
  • Performs periodic audits of the system for traceability, reliability, system adequacy, and procedural compliance.
  • Prepares document status reports for review by functional groups to expedite the action necessary for completing all associated documents required to close the record.
  • Prepares metrics or management reports to show progress to KPIs.
  • Organizes and files all controlled documents and manages the document control library.
  • Serves as investigator for departmental deviations, and implements assigned CAPAs.
  • Plays a lead role in Regulatory and Customer Audits.
  • All other documentation-related duties as assigned.
  • Subject Matter Expert (SME) for the QA Document Control function.
  • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identify opportunities for improvement. Make constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP, FDA, OSHA and other regulatory agencies.
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Requirements

  • Associate's degree or higher is required.
  • 4 years work experience in a Pharmaceutical company or other FDA regulated industry.
  • Knowledge of Quality and cGMP regulations for pharmaceutical industry (21 CFR Parts 210, 211 and Part 11) is required.
  • Strong computer skills to include but not limited to Microsoft Office (MS Word, Excel, Access, and PowerPoint). TrackWise skills are a plus.
  • Demonstrates excellent communication skills both written and verbal.
  • Experienced in problem solving with emphasis on strong interpersonal skills necessary to interact across various functional groups.
  • Must be flexible to adapt to changes in systems as the need arises while maintaining system compliance, document traceability, and history of change.
  • Strong organizational and follow-up skills required for quick response to document status change, ensuring that all critical documents are readily retrievable and are current.
  • Strong analytical skills required to gather, interpret and compile data into formalized reports and presentations, generate metrics and key performance indicator analysis.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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