Job Description

Quality Analyst/ Specialist – Quality Control

Scope of Responsibility: 

  • Work with team members and collaborate across departments on assigned projects.
  • Cost-effective management of entrusted resources.
  • Support Operations and Quality Programs.
  • Generate QC data and certificate of analysis for certified reference materials.

 

Purpose of the Position:

The key deliverables would be,

· Support Quality Control Release Testing of items manufactured at the MilliporeSigma-RTC site and other assigned projects.
· Work closely with senior team members on multiple aspects including data analysis, documentation, and data review to support the release of Certified Reference Materials, Reference Materials, and Analytical standards to the market.  Activities are aligned with ISO 9001, ISO/IEC 17025, and ISO 17034. 

 

  • Author MANGO document for the Audit

 

Essential Job Functions:

  • Undertake assigned projects, stability studies, writing of reports and batch records related to Certified Reference Material
  • Product & Application Development: process and evaluate analytical QC data generated- primarily by GC and HPLC
  • Follow regulatory, customer, and quality system requirements in product development.
  • Write reports on results of project work, document methods on project/product design, test specifications, etc.
  • Collaborate and work with other staff (Scientists and Technicians) remotely to complete QC data generation and analysis on Certified Reference Materials
  • Participate in training colleagues for technical transfer. Work with team and other departments to implement validation and tech transfer requirements
  • Contribute to project planning through communication with the manager, project manager, and team:
    • Identify and communicate resource requirements for specified projects
    • Provide timely updates and communicate project status to management and the project team
    • Communicate, in a timely manner, issues related to schedule, planning, and resources that may stall or prevent the execution of the project
  • Technical Expertise
    • Operation of chromatographic instrumentation including HPLC and GC
    • Operation of chromatographic detectors including UV-Vis, RI, MS, ELSD, ECD, FID, and others
    • Processing chromatographic data using chromatographic software
    • Utilizing Microsoft Excel to perform calculations
    • Develop and expand technical and subject matter expertise in assigned technical areas by seeking out training and knowledge-sharing
    • Technical project review of certificates for certified reference materials by mass balance techniques that may be traceable to primary pharmacopeias
  • Documentation
    • Write reports on results of project work, document methods on project/product design, test specifications, write batch records, test specifications etc. for transfer to QC.
    • Maintain batch records and other documentation.

 

BASIC QUALIFICATIONS

 

Education: A bachelor’s degree in chemistry, chemical engineering, or other related scientific discipline. 1 year of relevant experience in a scientific laboratory

 

Knowledge and Skills:

 

  • Demonstrated proficiency in basic analytical GC and HPLC techniques
  • Basic understanding of the relevant subject matter field (e.g., organic chemistry, analytical chemistry, process chemistry)
  • Demonstrated initiative and critical thinking to learn new skills and technologies.
  • Strong verbal and technical writing skills
  • Ability to utilize a variety of software tools involving databases, spreadsheets, and project scheduling.
  • Ability to work independently and prioritize assigned work
  • Ability to collaborate and communicate well with peers

 

ADDITIONAL LOCAL NEEDS

 

Environmental conditions:

Office Environment: Comfortable working in an office setting and collaborating virtually with a remote team.  May sit or stand at a desk working on a PC for long periods of time.

 

 

 

 

Signature of the SBS Manager                       Signature of the Global Manager

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