Documentation Specialist

The Staffing Resource Group, Inc
Published
August 22, 2020
Location
Houston, TX
Category
Job Type

Description

Technical Writer I

SRG offers flexible staffing solutions with a national presence.  We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent. 

  •        Title: Technical Writer I
  •        Location: Houston, TX 
  •        Industry: Pharmaceutical 
  •        Hours: Monday-Friday; 8:00 am – 5:00 pm 
  •        Salary: $25 - $32hr based on Experience Paid Weekly (Benefits are Available)
  •        Employment Type: 6-month contract     

Environment:  A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities.  The company’s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
 
Job Summary: 

  • Manufacturing Document Reviewer primary responsibility is the review of assigned manufacturing documentation and driving the subsequent corrections needed, prior to Quality review of each document. Documentation includes executed manufacturing batch records and ancillary documentation such as cell counts and equipment readouts, as well as logbooks, and GMP forms used in the production of Viral Vector (VV) Batches at the Lonza Houston Facility. Additional duties include updating and maintaining the document review tracker for VV Manufacturing. Manufacturing Document Reviewer are responsible for escalations to senior members and Supervisors of the team for complex issues that arise during review. A Manufacturing Document Reviewer demonstrates an understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, as well as additional professional skills of effective communication and listening. Training of junior staff may be requested for certain tasks.

Key Responsibilities:

  • Independent review and driver of associated corrections pertaining to manufacturing GMP records.
  • Review will be performed independently with minimal direction for the review process.
  • Minimal manufacturing process knowledge is required at this level.
  • Simple issues found during the review of documentation should be managed at this level to include identification of documentation errors. The Reviewer can identify when a nonconformance has occurred but may not understand GMP implications and appropriate actions to take without first obtaining feedback from either a Manufacturing Supervisor or Quality Assurance Specialist. These issues are escalated to Supervisors for mentoring through the process to gain the information required to make the appropriate decision.
  • Maintain document organization in specified document control area.
  • Update and maintain document review tracker.
  • Participate in routine meetings as assigned by supervision.
  • Train junior level reviewers and provide guidance as necessary.
  • Development of skill set to include - understanding of Quality Systems, Manufacturing, Good Documentation Practices, communication and listening.
  • Perform other duties as assigned.

  Key Skills Requirements:

  • BS/AS Science Degree
  • 1-2 years GMP experience
  • 1-2 years Document Review experience
  • Strong organizational skills and record keeping with the ability to work overtime when needed.
  • Ability to review large volumes of documents thoroughly in a timely manner, and follow up with personnel to correct any errors found.
  • Strong attention to detail and organizational skills.
  • Strong communication skills (written and oral).
  • Independent and self-motivated.
  • Familiarity with cGMP quality systems.
  • Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).

EOE/ADA 

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