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QC Investigator

Houston, TX

Posted: 02/10/2021 Job Number: JN -022021-12512

Job Description

QC Investigator III

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 match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: QC Investigator III
  • Location: Houston, TX
  • Industry: Pharmaceutical
  • Hours: Mon - Fri 8:00am - 5:00pm
  • Salary: $51.00hr based on experience (Benefits available)
  • Employment Type: Long Term Contract - 12 Months
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:

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.

Key responsibilities:
  • 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.
  • 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.
Key requirements:
  • Bachelor s degree in a relevant field of study is preferred.
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