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Quality Records Investigator / Deviation Investigation Writer

Houston, TX

Posted: 10/20/2020 Job Number: JN -102020-12105

Job Description

Quality Records Investigator / Deviation Investigation Writer

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: Quality Records Investigator / Deviation Investigation Writer

  • Location: Houston, TX

  • Industry: Pharmaceutical

  • Hours: Mon - Fri 8am - 5pm

  • Salary: $33hr based on experience

  • Employment Type: Long Term 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.

Key responsibilities:

Responsible for tracking, management, and completion of QC Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs. Leads error prevention and continuous improvement initiatives based on identified recurring root cause.
Serves as the Quality Record (PR) Subject Matter Expert (SME) for the Quality Control team
Leads complex technical investigations independently with occasional guidance and support
Drives closure of Quality Records by completing records per defined Standard Operating Procedures (SOPs) or by providing coaching and mentoring to record Authors and Contributors
Reviews and approves records for quality and consistency to ensure Right-First-Time approval by Quality Assurance and on-time closure of records
Monitors, analyzes and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time
Utilizes quality record data trends, cGMP knowledge and Lean Six Sigma philosophy (i.e. Gemba Walk, 5 Why s, Pareto Analysis) to actively identify, drive and implement continuous improvement / error prevention initiatives within the functional area
Provides training on Root Cause Analysis to record Authors and Contributors as necessary
Works on or leads other projects related to Error Prevent in response to identified CAPA
Performs other duties as assigned.

Technical Knowledge

  • Experience performing root-cause analysis, leading, and completing lab investigations
  • Prior experience working in a laboratory setting required
Knowledge
  • In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
Computer Skills
  • Proficient in the use of spreadsheets, databases, and word processing software.
  • Prior experience with TrackWise preferred
Decision Making
  • Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows.
Communication
  • Writing is typically free of punctuation, spelling and grammatical errors
  • Communicates verbally and in writing in a clear and concise manner.Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding.
  • Capable of effectively representing the department in meetings and on project teams. Provides timely, clear, and accurate updates without being prompted.
Teamwork
  • Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams.
  • Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.
Initiative
  • Actively attempts to understand the logic or basis for change in tasks or situations. Able to identify trends in testing.
  • Is optimistic and displays a positive attitude even during periods of adversity.
  • Is often the first to volunteer for specialized tasks.
  • Is considered a go-to person for assistance.
  • Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.

EOE/ADA

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